FDA Adverse Event
Injury
Summary report: N
MERIDIAN SR
MDR report key: 1041810
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34829
- 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
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERIDIAN SR | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS, INC | 1176 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | THE DEVICE 4137/282764 WAS IMPLANTED 18-MAR-2008| THE DEVICE 4088/200288 WAS IMPLANTED 02-SEP-2003| THE DEVICE 4137/245058 WAS IMPLANTED 16-JAN-2008| THE DEVICE 1198/144460 WAS IMPLANTED 18-MAR-2008 |