FDA Adverse Event
Malfunction
Summary report: N
IDENTITY DR
MDR report key: 1896154
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05284
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 12, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Removal / Correction Number
- Z2977
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW-UP, A MESSAGE WAS DIS- PLAYED INDICATING THAT AN ERROR IN PACEMAKER SOFTWARE HAD OCCURRED. THE PATIENT'S PRESENTING RHYTHM WAS 60 PPM, DDD PACED. A RATE OF 92 BPM WAS RECORDED ON THE MAGNET STRIP, INDICTING AN APPROXIMATE BATTERY VOLTAGE OF 2.64 V. ELECTIVE REPLACEMENT INDICATOR (ERI) HAD NOT BEEN REACHED. DUE TO TELEMETRY CORRUPTION, FURTHER TROUBLESHOOTING COULD NOT BE PERFORMED. THE DEVICE WAS EXPLANTED.
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 | 63 YR | Required Intervention |