FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA ULTRA
MDR report key: 1043001
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33642
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 19, 2008
- Report Date
- February 19, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DXY
- Removal / Correction Number
- Z0187-94/6
- 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 | INSIGNIA ULTRA | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS, INC | 1290 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | THE DEVICE 4457/428829 WAS IMPLANTED 10-MAY-2004| THE DEVICE 4470/426051 WAS IMPLANTED 10-MAY-2004 |