FDA Adverse Event
Injury
Summary report: N
IDENTITY XL DR
MDR report key: 2014260
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01758
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- January 17, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THE PULSE GENERATOR IN BACKUP VVI MODE DUE TO MULTIPLE FLIPPED BITS. THE PRODUCT CODE COULD NOT BE DOWNLOADED DUE TO BATTERY DEPLETION. AFTER REPLACING THE BATTERY AND DOWNLOADING THE PRODUCT CODE, NORMAL FUNCTION ENSUED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR WAS IN BACKUP VVI OPERATION AND COULD NOT BE RESTORED. A SOFTWARE DOWNLOAD WAS UNSUCCESSFUL. DEVICE WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5376 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |