FDA Adverse Event
Injury
Summary report: N
SETROX S 45
MDR report key: 2232566
·
Received August 19, 2011
Report
- Report Number
- 1028232-2011-01875
- Event Type
- Injury
- Date Received
- August 19, 2011
- Date of Event
- July 22, 2011
- Report Date
- August 11, 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
THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. THE HOSPITAL HAS RETAINED THIS DEVICE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
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 | 93 YR | Hospitalization |