FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1041850
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34785
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 26, 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 RELIANCE | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0147 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | THE DEVICE 4512/309711 WAS IMPLANTED 29-AUG-2002| THE DEVICE 6481 021429 WAS USED DURING THE EVENT.| THE DEVICE 4512/403331 WAS IMPLANTED 18-AUG-2004| THE DEVICE H175/505899 WAS IMPLANTED 18-AUG-2004| THE DEVICE 4469/317690 WAS IMPLANTED 29-AUG-2002 |