FDA Adverse Event
Injury
Summary report: N
MERIDIAN DR
MDR report key: 1041695
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34938
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 29, 2008
- Report Date
- March 29, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DXY
- Removal / Correction Number
- Z1032-39/5
- 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 | MERIDIAN DR | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS, INC | 1276 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | THE DEVICE 4450/202840 WAS IMPLANTED 08-MAY-2000| THE DEVICE 432-/87156R WAS IMPLANTED 08-MAY-2000 |