FDA Adverse Event
Injury
Summary report: N
INSIGNIA PLUS
MDR report key: 1041607
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-31940
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- November 1, 2006
- Report Date
- January 3, 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 PLUS | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS, INC | 1298 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | THE DEVICE 4470/351387 WAS IMPLANTED 21-APR-2003| THE DEVICE 4469/321464 WAS IMPLANTED 21-APR-2003| THE DEVICE 1291/132764 WAS IMPLANTED 14-FEB-2007 |