FDA Adverse Event
Injury
Summary report: N
VICTORY XL DR
MDR report key: 1223891
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03415
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 25, 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
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
HIGH CURRENT DRAIN FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH CURRENT DRAIN. THIS WAS CAUSED BY A DISCREPANT INTEGRATED CIRCUIT. AFTER REPLACING THE INTEGRATED CIRCUIT, NORMAL FUNCTION ENSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A POST IMPLANT CHECK, THE MEASURED BATTERY DATA WAS 2.61 V, 223 UA, AND LESS THAN 1 KOHMS. THE PULSE GENERATOR WAS UPDATED MULTIPLE TIMES AND THE MEASURED DATA SHOWED THE SAME VALUES. THE DEVICE WAS SUBSEQUENTLY REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VICTORY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5816 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |