FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX XL DR
MDR report key: 2240503
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05903
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- July 28, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND LOSS OF OUTPUT AND TELEMETRY DUE TO BATTERY DEPLETION. THE PULSE GENERATOR WAS FOUND IN BACKUP MODE DUE TO MULTIPLE FLIPPED BITS. AFTER DOWNLOADING THE PRODUCT CODE, THE DEVICE FUNCTIONED NORMALLY EXCEPT THE BATTERY VOLTAGE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR WAS IN BACKUP OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5386 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Required Intervention |