FDA Adverse Event
Injury
Summary report: N
KENTROX SL-S 65/16 STEROID
MDR report key: 1201555
·
Received October 16, 2008
Report
- Report Number
- 1028232-2008-01046
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 17, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER OOS, THE PACE/SENSE PORTION OF THIS LEAD WAS CAPPED DUE TO HIGH PACING THRESHOLDS. THE PACE/SENSE POTION OF THIS LEAD WAS REPLACED WITH A SETROX S 60.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENTROX SL-S 65/16 STEROID | ICD LEAD | LWS | BIOTRONIK GMBH AND CO. | 345988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization |