FDA Adverse Event
Injury
Summary report: N
SELOX JT 53
MDR report key: 1221854
·
Received November 3, 2008
Report
- Report Number
- 1028232-2008-01318
- Event Type
- Injury
- Date Received
- November 3, 2008
- Date of Event
- September 25, 2008
- Report Date
- September 30, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER OOS, THIS LEAD "WAS REPLACED WITH AN ACTIVE FIXATION, TO PREVENT LEAD DISLODGMENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX JT 53 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 346368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization |