FDA Adverse Event
Malfunction
Summary report: N
KENTROX SL-S 65/16
MDR report key: 1013215
·
Received March 12, 2008
Report
- Report Number
- 1028232-2008-00243
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 4, 2008
- Report Date
- February 18, 2008
- Manufacturer
- BIOTRONIK, GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS LEAD WAS RETURNED WITH OOS DOCUMENTATION. THE PT WAS IN A CAR ACCIDENT. FOLLOWING THIS, THE DEVICE HAD OVERSENSING ISSUES AND GAVE INAPPROPRIATE SHOCKS. THIS LEAD WAS REPLACED WITH A LINOX. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENTROX SL-S 65/16 | ICD LEAD | LWS | BIOTRONIK, GMBH AND CO. | 347351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization |