FDA Adverse Event
Malfunction
Summary report: N
KENTROX SL-S 65/16 STEROID
MDR report key: 2030311
·
Received March 21, 2011
Report
- Report Number
- 1028232-2011-00601
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 8, 2011
- Report Date
- March 9, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THIS LEAD WAS CAPPED AND REPLACED DUE TO NOISE BEING SENSED ON THE LEAD. IMPEDANCE WAS GREATER THAN 200 OHMS. THERE WERE NO OTHER ADVERSE PT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENTROX SL-S 65/16 STEROID | ICD LEAD | LWS | BIOTRONIK SE & CO. KG | 342397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization |