FDA Adverse Event
Malfunction
Summary report: N
ATRIAL J SELUTE PICOTIP
MDR report key: 1042315
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34326
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 4, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATRIAL J SELUTE PICOTIP | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4063 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other | THE DEVICE 1283/625998 WAS IMPLANTED 14-DEC-2001| THE DEVICE 1296/142720 WAS IMPLANTED 04-MAR-2008| THE DEVICE 4034/304238 WAS IMPLANTED 14-DEC-2001| THE DEVICE 4135/244509 WAS IMPLANTED 04-MAR-2008 |