FDA Adverse Event
Malfunction
Summary report: N
LINOX SD 75/18
MDR report key: 1150124
·
Received August 29, 2008
Report
- Report Number
- 1028232-2008-01063
- Event Type
- Malfunction
- Date Received
- August 29, 2008
- Date of Event
- July 29, 2008
- Report Date
- August 1, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS LEAD WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REP. THIS LEAD WAS REMOVED DUE TO NOISE. THIS LEAD WAS REPLACED WITH LINOX S 75.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 75/18 | ICD LEAD | LWS | BIOTRONIK GMBH AND CO. | 350056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |