FDA Adverse Event
Injury
Summary report: N
INSIGNIA ULTRA
MDR report key: 1042039
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34610
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 18, 2008
- Report Date
- March 18, 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
- NY, US
- Reporter Occupation
- PHYSICIAN
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 | 88 YR | Required Intervention | THE DEVICE 4271/218178 WAS IMPLANTED 27-APR-1998| THE DEVICE 4285/245185 WAS IMPLANTED 27-APR-1998| THE DEVICE 1290/805798 WAS IMPLANTED 18-MAR-2008 |