FDA Adverse Event
Injury
Summary report: N
LINOX TD 65/18
MDR report key: 1221845
·
Received November 3, 2008
Report
- Report Number
- 1028232-2008-01314
- Event Type
- Injury
- Date Received
- November 3, 2008
- Date of Event
- September 17, 2008
- Report Date
- October 1, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER OOS, THIS LEAD WAS REPOSITIONED DUE TO HIGH THRESHOLDS. THE LEAD WAS NOT LONG ENOUGH, SO THE PHYSICIAN REPLACED IT WITH A LINOX TD 75/18.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX TD 65/18 | ICD LEAD | LWS | BIOTRONIK GMBH AND CO. | 351338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |