FDA Adverse Event
Injury
Summary report: N
ENDOTAK C
MDR report key: 1253878
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40741
- Event Type
- Injury
- Date Received
- November 11, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 19, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK C | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0072 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | THE DEVICE E102/003172 WAS IMPLANTED 19-SEP-2008| THE DEVICE 1705/662180 WAS IMPLANTED 05-JAN-1993| THE DEVICE 0185/211229 WAS IMPLANTED 19-SEP-2008| THE DEVICE 1857/703348 WAS IMPLANTED 19-NOV-2004| THE DEVICE 1725/252065 WAS IMPLANTED 16-JAN-1996| THE DEVICE 0063/001987 WAS IMPLANTED 05-JAN-1993| THE DEVICE 0048/000630 WAS IMPLANTED 05-JAN-1993| THE DEVICE 1796/500237 WAS IMPLANTED 10-DEC-1999| THE DEVICE E102/003536 WAS IMPLANTED| THE DEVICE 6836/003828 WAS IMPLANTED 05-JAN-1993 |