FDA Adverse Event
Injury
Summary report: N
INSIGNIA ULTRA
MDR report key: 1042670
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33981
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 28, 2008
- Report Date
- February 28, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DXY
- Removal / Correction Number
- Z0187-94/6
- Adverse Event
- Yes
- 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 | 63 YR | Required Intervention | THE DEVICE 404-/OMH121 WAS IMPLANTED 09-JAN-1992| THE DEVICE 404-/ WAS IMPLANTED 09-JAN-1992| THE DEVICE 404-/ WAS IMPLANTED 09-JAN-1992| THE DEVICE 1276/403045 WAS IMPLANTED 17-FEB-1999| THE DEVICE 284-/27060 WAS IMPLANTED 09-JAN-1992| THE DEVICE 404-/OMH120 WAS IMPLANTED 09-JAN-1992 |