FDA Adverse Event
Injury
Summary report: N
SETROX S 45
MDR report key: 6109024
·
Received November 17, 2016
Report
- Report Number
- 1028232-2016-04628
- Event Type
- Injury
- Date Received
- November 17, 2016
- Date of Event
- July 9, 2010
- Report Date
- November 11, 2016
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.
Description of Event or Problem · 1
THE ATRIAL LEAD SHOWED NO SIGNS OF ACTIVITY ON POST-OP INTERROGATION, SUGGESTING THAT THE LEAD WAS NOT CONNECTED PROPERLY WITH THE GENERATOR. SUSPECTED GENERATOR FAILURE REQUIRING OPENING OF PACEMAKER POCKET. THE ATRIAL LEAD WAS REMOVED FROM THE GENERATOR AND TESTED INDEPENDENTLY. THE GENERATOR WAS REMOVED FROM THE POCKET AND IRRIGATED WITH ANTIBIOTICS. BOTH DEVICES REMAINED IMPLANTED AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 762018 | SETROX S 45 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 350973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization |