FDA Adverse Event
Malfunction
Summary report: N
IDENTITY DR
MDR report key: 1050538
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01509
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- March 20, 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
- SC
- 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 BACK-UP MODE. TWO ATTEMPTS TO PERFORM A DOWNLOAD FAILED. THE ELECTIVE REPLACEMENT INDICATOR (ERI) BYTE INDICATED THAT THE DEVICE HAD NOT REACHED 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 |