FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA ULTRA
MDR report key: 1254197
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-41028
- Event Type
- Malfunction
- Date Received
- November 11, 2008
- Date of Event
- September 26, 2008
- Report Date
- September 26, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DXY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA ULTRA | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS, INC | 1291 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other | THE DEVICE 4087/259289 WAS IMPLANTED 21-DEC-2006| THE DEVICE 4088/222384 WAS IMPLANTED 21-DEC-2006 |