FDA Adverse Event
Malfunction
Summary report: N
IDENTITY DR
MDR report key: 1051018
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01325
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- February 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- Z2977
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR WAS IN BACKUP VVI MODE AND COULD NOT BE RESTORED. ATTEMPTS TO DOWNLOAD THE SOFTWARE RESULTED IN THE MESSAGE "OPERATION FAILED". THE DEVICE WAS NOT AT ELECTIVE REPLACEMENT INDICATOR (ERI).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5370 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |