FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK ENDURANCE RX
MDR report key: 1042362
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34289
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 11, 2008
- Report Date
- March 11, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- 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 ENDURANCE RX | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0145 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other | THE DEVICE 4054/415070 WAS IMPLANTED 29-AUG-2000| THE DEVICE 6482 021038 WAS USED DURING THE EVENT.| THE DEVICE 4538/163026 WAS IMPLANTED 05-SEP-2007| THE DEVICE H210/213566 WAS IMPLANTED 05-SEP-2007 |