FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX SR
MDR report key: 1896601
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05264
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- October 21, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR EXHIBITED HIGH CURRENT DRAIN DUE TO A DISCREPANT INTEGRATED CIRCUIT, RESULTING IN PREMATURE BATTERY DEPLETION. AFTER REPLACING THE INTEGRATED CIRCUIT, NORMAL FUNCTION ENSUED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE MONTH POST IMPLANT, THE PULSE GEN- ERATOR INDICATED A BATTERY VOLTAGE OF 2.68 V, CURRENT DRAIN 76 UA WITH A REMAINING LONGEVITY OF 0.25 - 0.5 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5180 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |