FDA Adverse Event
Other
Summary report: N
ST JUDE MEDICAL
MDR report key: 389765
·
Received April 22, 2002
Report
- Report Number
- MW1024782
- Event Type
- Other
- Date Received
- April 22, 2002
- Date of Event
- January 3, 2002
- Report Date
- January 11, 2002
- Manufacturer
- ST JUDE MEDICAL
- Product Code
- DXY
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DUAL CHAMBER PERMANENT PACER GENERATOR FAILURE NOTED IMMEDIATELY AFTER INSERTION WHILE IN RECOVERY ROOM. RETURNED TO OR FOR REINSERTION OF ANOTHER PACER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ST JUDE MEDICAL | BIPOLAR PERMANENT IMPLANTABLE GENERATOR | DXY | ST JUDE MEDICAL | 5346 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other | MODEL # 5346 ST JUDE MEDICAL PACER GENERATOR. |