FDA Adverse Event
Injury
Summary report: N
LINOX TD 65/18
MDR report key: 1689779
·
Received May 11, 2010
Report
- Report Number
- 1028232-2010-00991
- Event Type
- Injury
- Date Received
- May 11, 2010
- Date of Event
- March 31, 2010
- Report Date
- April 13, 2010
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER (B) (4) ADVERSE EVENT REPORT, THIS LEAD DISLODGED AND WAS REPLACED WITH ANOTHER LINOX SD 65/18, (B) (4). ON 04/20/2010 - THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX TD 65/18 | ICD LEAD | LWS | BIOTRONIK SE & CO. KG | 351338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization |