FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE S
MDR report key: 1043085
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33558
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 15, 2008
- Report Date
- February 15, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- 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 S | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 0127 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | THE DEVICE 1900/100511 WAS IMPLANTED 10-APR-2002| THE DEVICE 438-/07765M WAS IMPLANTED 25-MAR-1998| THE DEVICE 6330/001114 WAS IMPLANTED 25-MAR-1998| THE DEVICE 6330/001149 WAS IMPLANTED 25-MAR-1998| THE DEVICE 6331/103542 WAS IMPLANTED 25-MAR-1998| THE DEVICE 6332 103855 WAS USED DURING THE EVENT.| THE DEVICE 6835/205303 WAS IMPLANTED 01-NOV-2005| THE DEVICE A155/113864 WAS IMPLANTED 01-NOV-2005 |