FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR POROUS
MDR report key: 1041839
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34802
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 26, 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 | BIPOLAR POROUS | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4271 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | THE DEVICE 1298/163151 WAS IMPLANTED 03-NOV-2003| THE DEVICE 4285/237708 WAS IMPLANTED 08-NOV-1997 |