FDA Adverse Event
Injury
Summary report: N
IDENTITY SR
MDR report key: 1223886
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03420
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 19, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMAP880086
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACK-UP MODE DUE TO MULTIPLE FLIPPED BITS. THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO NORMAL BATTERY DEPLETION. AFTER REPLACING THE BATTERY AND DOWNLOADING THE PRODUCT CODE THE DEVICE FUNCTIONED NORMALLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR WAS IN BACKUP VVI. THE PATIENT'S PRESENTING RHYTHM WAS 67.5 PULSES PER MINUTE VVI PACED. THE DEVICE STATUS REPORT WOULD NOT PRINT, THE ERROR MESSAGE "OPERATION FAILED" DISPLAYED, AND A TELEMETRY TEST ALSO FAILED. THE DEVICE WAS REPLACED DUE TO UNRESOLVED BACKUP VVI STATUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5172 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |