FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX DR
MDR report key: 1222967
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03256
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 22, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- 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 TESTING COULD NOT BE PERFORMED AND BATTERY DATA COULD NOT BE RETRIEVED DURING INTERROGATION. THERE WERE NO ALERTS AND THE DEVICE DID NOT APPEAR TO HAVE HAD AN ELECTIVE REPLACEMENT INDICATOR (ERI) TRIP. PREVIOUS INTERROGATION IN 2008, SHOWED BATTERY DATA OF 2.54 V, 10 UA, AND 14.7 K, WITH AN ESTIMATED REMAINING LONGEVITY OF 0.5 YEARS TO ERI. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5380 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |