FDA Adverse Event
Injury
Summary report: N
ENDOTAK C
MDR report key: 1041892
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34743
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 12, 2008
- Report Date
- March 12, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK C | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0064 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |