FDA Adverse Event
Injury
Summary report: N
INSIGNIA ULTRA
MDR report key: 1042224
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34430
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 14, 2008
- Report Date
- March 14, 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 | 1291 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | THE DEVICE 4039/BIT377 WAS IMPLANTED 13-APR-2005| THE DEVICE 4457/470203 WAS IMPLANTED 13-APR-2005 |