FDA Adverse Event
Injury
Summary report: N
MERIDIAN DDD
MDR report key: 1043334
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33303
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 8, 2008
- Report Date
- February 8, 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 DDD | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS, INC | 0976 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | THE DEVICE 4456/300068 WAS IMPLANTED 02-JUL-2001| THE DEVICE 4016/BIQ109 WAS IMPLANTED 19-MAY-2000| THE DEVICE 4034/215586 WAS IMPLANTED 19-MAY-2000| THE DEVICE 4063/302450 WAS IMPLANTED 02-JUL-2001| THE DEVICE 1290/763458 WAS IMPLANTED 28-FEB-2007| THE DEVICE 1280/508612 WAS IMPLANTED 02-JUL-2001 |