FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX DR
MDR report key: 1223866
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03435
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 8, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
HIGH CURRENT DRAIN FINAL ANALYSIS FOUND HIGH CURRENT DRAIN MEASURED AT LOW PROGRAMMED PULSE AMPLITUDES, DUE TO A DEFECTIVE CAPACITOR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED HIGH CURRENT DRAIN. THE DEVICE OUTPUT WAS PROGRAMMED TO 3.0 V. THE DEVICE WAS REPLACED, DUE TO ELECTIVE REPLACEMENT INDICATOR.
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 |