FDA Adverse Event
Malfunction
Summary report: N
SYNOX SX 45 -JBP
MDR report key: 1122174
·
Received August 15, 2008
Report
- Report Number
- 1028232-2008-00924
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- July 15, 2008
- Report Date
- July 21, 2008
- Manufacturer
- BIOTRONIK, GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- K980869
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER OOS, THIS LEAD WAS REMOVED DURING A DEVICE CHANGEOUT DUE TO INTERMITTENT UNDERSENSING. THIS LEAD WAS REPLACED WITH A SETROX S 45.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNOX SX 45 -JBP | PACER LEAD | DTB | BIOTRONIK, GMBH AND CO. | 120438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |