FDA Adverse Event
Injury
Summary report: N
IDENTITY XL DR
MDR report key: 2014040
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01740
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- January 6, 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 Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THE PULSE GENERATOR IN BACKUP MODE. THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY. 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 EXHIBITED ELECTIVE REPLACEMENT INDICATOR (ERI). MEASURED BATTERY DATA WAS 2.51 V, 7 UA, 16.3 KOHMS. THE ERI TRIP DATE WAS (B)(6) 2010. SIX MONTHS PRIOR, MEASURED BATTERY DATA WAS 2.69 V, 8.0 UA, 6.1 KOHMS AND THE PROGRAMMER DISPLAYED 1.75 - 2.0 YEARS. THE PROGRAMMED SETTINGS WERE AAIR, 60 PPM, 2.5 V AT 0.5 MS. THE DEVICE WAS REMOVED AND REPLACED.
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 | 79 YR | Required Intervention |