FDA Adverse Event
Malfunction
Summary report: N
SELOX SR 53
MDR report key: 1121207
·
Received August 15, 2008
Report
- Report Number
- 1028232-2008-00936
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 23, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS SYSTEM WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE. PER OOS, "THERE ARE ARTIFACTS ON BOTH LEAD, AND LEAD ABRASIONS. THIS PATIENT RECEIVED INAPPROPRIATE SHOCKED DUE TO NOISE ON BOTH ATRIAL AND VENTRICULAR PACE/SENSE LEADS." ALSO REMOVED: KENTROX SL-S 65/16 STEROID, MDR 1028232-2008-00935.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX SR 53 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 343083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |