| Patients number . | SAEs . | Event . | Time of event (days post-implant) . | Expected . | Intervention . | Relatedness to procedure or system . | Outcome . |
|---|---|---|---|---|---|---|---|
| 0001 | 2 | Syncope facilitated by dehydration | 154 | N | Reduce diuretics | Possibly related | Resolved |
| 0006 | 1 | Cardiac decompensation due to worsening of HF | 195 | Y | Diuretic therapy | Probably not related | Resolved |
| 0006 | 1 | Cardiac decompensation due to worsening of HF | 211 | Y | Diuretic therapy | Probably not related | Resolved |
| 0010 | 1 | Re-acutization of chronic bronchitis | 41 | N | Hospitalization medication change including antibiotics | Probably not related. Patient had chronic bronchitis | Resolved |
| 0010 | 1 | Re-acutization of chronic bronchitis | 190 | N | Hospitalization medication change including antibiotics | Probably not related. Patient had chronic bronchitis | Resolved |
| 0101 | 1 | Salivary gland tumour | 57 | N | Complete tumour–resection | Certainly not related | Resolved |
| 0101 | 1 | Non persistent ST elevation myocardial infarction | 118 | N | Hospitalization | Probably not related | Resolved |
| 0202 | 1 | Pulmonary oedema after device implantation | 1 | Y | Medications (i.v. diuretics) | Certainly related to procedure | Resolved |
| 0202 | 1 | Death due to worsening of End stage HF | 116 | Y | Probably not related | Death | |
| 0204 | 1 | Cardiac device revision caused by incomplete insertion of stimulation lead | 129 | Y | Surgery | Certainly related to procedure | Resolved |
| 0404 | 1 | Cardiac decompensation due to worsening of HF and depression | 41 | Y | Diuretics and antidepressants | Probably not related | Resolved |
| 0404 | 1 | Death due to worsening of end stage HF | 76 | Y | Probably not related | Death | |
| 0405 | 1 | ICD shocks due to ventricular tachycardias | 150 | Y | Hospitalization medication change | Probably not related | Resolved |
| 0501 | 1 | Pleural effusion due to worsening of HF | 48 | Y | i.v. diuretics | Probably not related | Resolved |
| 0502 | 1 | Cardiac decompensation | 134 | Y | i.v. diuretics; hospitalization | Probably not related | Resolved |
| 0504 | 1 | Haemianopsy due to transient ischemic attack from left posterior cerebral artery | 42 | N | Hospitalization; head computerized tomography | Probably not related | Resolved |
| 0504 | 1 | Syncope associated with new onset atrial fibrillation and hypotension | 50 | N | Hospitalization | Possibly related to system (patient collapsed after removing the magnet and resumption of stimulations) | Resolved |
| 0504 | 1 | Cardiac decompensation due to worsening of end stage HF | 115 | Y | Medication change | Probably not related | Death |
| 0505 | 1 | Cardiac decompensation | 100 | Y | Hospitalization; diuretics | Probably not related | Resolved |
| 0505 | 1 | Cardiac decompensation | 160 | Y | Hospitalization | Probably not related | Resolved |
| 0505 | 1 | Atrial Fibrillation | 167 | Y | Hospitalization for cardioversion | Possibly related | Resolved |
| 0505 | 1 | Return to atrial fibrillation after conversion | 168 | Y | No action taken | Possibly related | Resolved |
| 0505 | 1 | Cardiac decompensation | 190 | Y | Hospitalization; diuretics | Probably not related | Resolved |
| 0602 | 1 | Hyperglycaemia caused by diabetes | 94 | N | Hospitalization; insulin | Probably not related | Resolved |
| 0602 | 1 | Abdominal tension associated with pre-existing Hepatopathy | 155 | N | Hospitalization for abdomen computerized tomography | Probably not related | Resolved |
| Patients number . | SAEs . | Event . | Time of event (days post-implant) . | Expected . | Intervention . | Relatedness to procedure or system . | Outcome . |
|---|---|---|---|---|---|---|---|
| 0001 | 2 | Syncope facilitated by dehydration | 154 | N | Reduce diuretics | Possibly related | Resolved |
| 0006 | 1 | Cardiac decompensation due to worsening of HF | 195 | Y | Diuretic therapy | Probably not related | Resolved |
| 0006 | 1 | Cardiac decompensation due to worsening of HF | 211 | Y | Diuretic therapy | Probably not related | Resolved |
| 0010 | 1 | Re-acutization of chronic bronchitis | 41 | N | Hospitalization medication change including antibiotics | Probably not related. Patient had chronic bronchitis | Resolved |
| 0010 | 1 | Re-acutization of chronic bronchitis | 190 | N | Hospitalization medication change including antibiotics | Probably not related. Patient had chronic bronchitis | Resolved |
| 0101 | 1 | Salivary gland tumour | 57 | N | Complete tumour–resection | Certainly not related | Resolved |
| 0101 | 1 | Non persistent ST elevation myocardial infarction | 118 | N | Hospitalization | Probably not related | Resolved |
| 0202 | 1 | Pulmonary oedema after device implantation | 1 | Y | Medications (i.v. diuretics) | Certainly related to procedure | Resolved |
| 0202 | 1 | Death due to worsening of End stage HF | 116 | Y | Probably not related | Death | |
| 0204 | 1 | Cardiac device revision caused by incomplete insertion of stimulation lead | 129 | Y | Surgery | Certainly related to procedure | Resolved |
| 0404 | 1 | Cardiac decompensation due to worsening of HF and depression | 41 | Y | Diuretics and antidepressants | Probably not related | Resolved |
| 0404 | 1 | Death due to worsening of end stage HF | 76 | Y | Probably not related | Death | |
| 0405 | 1 | ICD shocks due to ventricular tachycardias | 150 | Y | Hospitalization medication change | Probably not related | Resolved |
| 0501 | 1 | Pleural effusion due to worsening of HF | 48 | Y | i.v. diuretics | Probably not related | Resolved |
| 0502 | 1 | Cardiac decompensation | 134 | Y | i.v. diuretics; hospitalization | Probably not related | Resolved |
| 0504 | 1 | Haemianopsy due to transient ischemic attack from left posterior cerebral artery | 42 | N | Hospitalization; head computerized tomography | Probably not related | Resolved |
| 0504 | 1 | Syncope associated with new onset atrial fibrillation and hypotension | 50 | N | Hospitalization | Possibly related to system (patient collapsed after removing the magnet and resumption of stimulations) | Resolved |
| 0504 | 1 | Cardiac decompensation due to worsening of end stage HF | 115 | Y | Medication change | Probably not related | Death |
| 0505 | 1 | Cardiac decompensation | 100 | Y | Hospitalization; diuretics | Probably not related | Resolved |
| 0505 | 1 | Cardiac decompensation | 160 | Y | Hospitalization | Probably not related | Resolved |
| 0505 | 1 | Atrial Fibrillation | 167 | Y | Hospitalization for cardioversion | Possibly related | Resolved |
| 0505 | 1 | Return to atrial fibrillation after conversion | 168 | Y | No action taken | Possibly related | Resolved |
| 0505 | 1 | Cardiac decompensation | 190 | Y | Hospitalization; diuretics | Probably not related | Resolved |
| 0602 | 1 | Hyperglycaemia caused by diabetes | 94 | N | Hospitalization; insulin | Probably not related | Resolved |
| 0602 | 1 | Abdominal tension associated with pre-existing Hepatopathy | 155 | N | Hospitalization for abdomen computerized tomography | Probably not related | Resolved |
| Patients number . | SAEs . | Event . | Time of event (days post-implant) . | Expected . | Intervention . | Relatedness to procedure or system . | Outcome . |
|---|---|---|---|---|---|---|---|
| 0001 | 2 | Syncope facilitated by dehydration | 154 | N | Reduce diuretics | Possibly related | Resolved |
| 0006 | 1 | Cardiac decompensation due to worsening of HF | 195 | Y | Diuretic therapy | Probably not related | Resolved |
| 0006 | 1 | Cardiac decompensation due to worsening of HF | 211 | Y | Diuretic therapy | Probably not related | Resolved |
| 0010 | 1 | Re-acutization of chronic bronchitis | 41 | N | Hospitalization medication change including antibiotics | Probably not related. Patient had chronic bronchitis | Resolved |
| 0010 | 1 | Re-acutization of chronic bronchitis | 190 | N | Hospitalization medication change including antibiotics | Probably not related. Patient had chronic bronchitis | Resolved |
| 0101 | 1 | Salivary gland tumour | 57 | N | Complete tumour–resection | Certainly not related | Resolved |
| 0101 | 1 | Non persistent ST elevation myocardial infarction | 118 | N | Hospitalization | Probably not related | Resolved |
| 0202 | 1 | Pulmonary oedema after device implantation | 1 | Y | Medications (i.v. diuretics) | Certainly related to procedure | Resolved |
| 0202 | 1 | Death due to worsening of End stage HF | 116 | Y | Probably not related | Death | |
| 0204 | 1 | Cardiac device revision caused by incomplete insertion of stimulation lead | 129 | Y | Surgery | Certainly related to procedure | Resolved |
| 0404 | 1 | Cardiac decompensation due to worsening of HF and depression | 41 | Y | Diuretics and antidepressants | Probably not related | Resolved |
| 0404 | 1 | Death due to worsening of end stage HF | 76 | Y | Probably not related | Death | |
| 0405 | 1 | ICD shocks due to ventricular tachycardias | 150 | Y | Hospitalization medication change | Probably not related | Resolved |
| 0501 | 1 | Pleural effusion due to worsening of HF | 48 | Y | i.v. diuretics | Probably not related | Resolved |
| 0502 | 1 | Cardiac decompensation | 134 | Y | i.v. diuretics; hospitalization | Probably not related | Resolved |
| 0504 | 1 | Haemianopsy due to transient ischemic attack from left posterior cerebral artery | 42 | N | Hospitalization; head computerized tomography | Probably not related | Resolved |
| 0504 | 1 | Syncope associated with new onset atrial fibrillation and hypotension | 50 | N | Hospitalization | Possibly related to system (patient collapsed after removing the magnet and resumption of stimulations) | Resolved |
| 0504 | 1 | Cardiac decompensation due to worsening of end stage HF | 115 | Y | Medication change | Probably not related | Death |
| 0505 | 1 | Cardiac decompensation | 100 | Y | Hospitalization; diuretics | Probably not related | Resolved |
| 0505 | 1 | Cardiac decompensation | 160 | Y | Hospitalization | Probably not related | Resolved |
| 0505 | 1 | Atrial Fibrillation | 167 | Y | Hospitalization for cardioversion | Possibly related | Resolved |
| 0505 | 1 | Return to atrial fibrillation after conversion | 168 | Y | No action taken | Possibly related | Resolved |
| 0505 | 1 | Cardiac decompensation | 190 | Y | Hospitalization; diuretics | Probably not related | Resolved |
| 0602 | 1 | Hyperglycaemia caused by diabetes | 94 | N | Hospitalization; insulin | Probably not related | Resolved |
| 0602 | 1 | Abdominal tension associated with pre-existing Hepatopathy | 155 | N | Hospitalization for abdomen computerized tomography | Probably not related | Resolved |
| Patients number . | SAEs . | Event . | Time of event (days post-implant) . | Expected . | Intervention . | Relatedness to procedure or system . | Outcome . |
|---|---|---|---|---|---|---|---|
| 0001 | 2 | Syncope facilitated by dehydration | 154 | N | Reduce diuretics | Possibly related | Resolved |
| 0006 | 1 | Cardiac decompensation due to worsening of HF | 195 | Y | Diuretic therapy | Probably not related | Resolved |
| 0006 | 1 | Cardiac decompensation due to worsening of HF | 211 | Y | Diuretic therapy | Probably not related | Resolved |
| 0010 | 1 | Re-acutization of chronic bronchitis | 41 | N | Hospitalization medication change including antibiotics | Probably not related. Patient had chronic bronchitis | Resolved |
| 0010 | 1 | Re-acutization of chronic bronchitis | 190 | N | Hospitalization medication change including antibiotics | Probably not related. Patient had chronic bronchitis | Resolved |
| 0101 | 1 | Salivary gland tumour | 57 | N | Complete tumour–resection | Certainly not related | Resolved |
| 0101 | 1 | Non persistent ST elevation myocardial infarction | 118 | N | Hospitalization | Probably not related | Resolved |
| 0202 | 1 | Pulmonary oedema after device implantation | 1 | Y | Medications (i.v. diuretics) | Certainly related to procedure | Resolved |
| 0202 | 1 | Death due to worsening of End stage HF | 116 | Y | Probably not related | Death | |
| 0204 | 1 | Cardiac device revision caused by incomplete insertion of stimulation lead | 129 | Y | Surgery | Certainly related to procedure | Resolved |
| 0404 | 1 | Cardiac decompensation due to worsening of HF and depression | 41 | Y | Diuretics and antidepressants | Probably not related | Resolved |
| 0404 | 1 | Death due to worsening of end stage HF | 76 | Y | Probably not related | Death | |
| 0405 | 1 | ICD shocks due to ventricular tachycardias | 150 | Y | Hospitalization medication change | Probably not related | Resolved |
| 0501 | 1 | Pleural effusion due to worsening of HF | 48 | Y | i.v. diuretics | Probably not related | Resolved |
| 0502 | 1 | Cardiac decompensation | 134 | Y | i.v. diuretics; hospitalization | Probably not related | Resolved |
| 0504 | 1 | Haemianopsy due to transient ischemic attack from left posterior cerebral artery | 42 | N | Hospitalization; head computerized tomography | Probably not related | Resolved |
| 0504 | 1 | Syncope associated with new onset atrial fibrillation and hypotension | 50 | N | Hospitalization | Possibly related to system (patient collapsed after removing the magnet and resumption of stimulations) | Resolved |
| 0504 | 1 | Cardiac decompensation due to worsening of end stage HF | 115 | Y | Medication change | Probably not related | Death |
| 0505 | 1 | Cardiac decompensation | 100 | Y | Hospitalization; diuretics | Probably not related | Resolved |
| 0505 | 1 | Cardiac decompensation | 160 | Y | Hospitalization | Probably not related | Resolved |
| 0505 | 1 | Atrial Fibrillation | 167 | Y | Hospitalization for cardioversion | Possibly related | Resolved |
| 0505 | 1 | Return to atrial fibrillation after conversion | 168 | Y | No action taken | Possibly related | Resolved |
| 0505 | 1 | Cardiac decompensation | 190 | Y | Hospitalization; diuretics | Probably not related | Resolved |
| 0602 | 1 | Hyperglycaemia caused by diabetes | 94 | N | Hospitalization; insulin | Probably not related | Resolved |
| 0602 | 1 | Abdominal tension associated with pre-existing Hepatopathy | 155 | N | Hospitalization for abdomen computerized tomography | Probably not related | Resolved |
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