FDA Adverse Event
Injury
Summary report: N
SETROX S 45
MDR report key: 2162163
·
Received July 7, 2011
Report
- Report Number
- 1028232-2011-01479
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 27, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE PATIENT WAS LIFTING WEIGHT APPROXIMATELY 3 MONTHS POST IMPLANT, WHICH RESULTED IN DISLODGEMENT. THE PHYSICIAN ATTEMPTED TO REPOSITION THIS LEAD, BUT TISSUE IN THE HELIX PREVENTED A STABLE POSITION. THIS LEAD WAS EXPLANTED AND HAS BEEN RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 45 | PACER LEAD | NVZ | BIOTRONIK SE & CO. KG | 350973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization |