FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1042561
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34095
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 4, 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 | 0157 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | THE DEVICE 4543/130722 WAS IMPLANTED 31-AUG-2007| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6482 023837 WAS USED DURING THE EVENT.| THE DEVICE H210/213740 WAS IMPLANTED 31-AUG-2007| THE DEVICE 425-/T1L287 WAS IMPLANTED 20-NOV-1995| THE DEVICE 438-/13315M WAS IMPLANTED 07-MAY-1998 |