FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK SQ PATCH
MDR report key: 1042072
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34559
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 17, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK SQ PATCH | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0063 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other | THE DEVICE 0062/000855 WAS IMPLANTED 05-SEP-1991| THE DEVICE 1857/704893 WAS IMPLANTED 17-MAR-2008| THE DEVICE 1857/701794 WAS IMPLANTED 27-JAN-2004| THE DEVICE 6836/001494 WAS IMPLANTED 05-SEP-1991 |