FDA Adverse Event
Malfunction
Summary report: N
KENTROX SL-S 65/16 STEROID
MDR report key: 1121224
·
Received August 15, 2008
Report
- Report Number
- 1028232-2008-00934
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- July 10, 2008
- Report Date
- July 21, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER OOS, THIS LEAD WAS REMOVED DUE TO INTERMITTENT OVERSENSING AND NOISE ON BOTH THE ATRIAL AND VENTRICULAR CHANNELS AS WELL AS A SUDDEN PUMP IN THE ATRIAL IMPEDANCE DETECTED BY HOME MONITORING. NO INAPPROPRIATE SHOCKS WERE DELIVERED. THIS LEAD WAS REPLACED WITH A LINOX SD 65/18. ALSO REMOVED WAS A SELOX SR 53, MDR 1028232-2008-00933.
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 | 47 YR | Hospitalization |