FDA Adverse Event
Injury
Summary report: N
VICTORY XL DR
MDR report key: 1073213
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02027
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 20, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
A FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS IMPLANTED FOR 1.54 YEARS, 4.425 YEARS LESS THAN THE EXPECTED 75% PUBLISHED LONGEVITY. BATTERY CURRENT WAS IN THE NORMAL RANGE. NO INFORMATION WAS RECEIVED FROM THE FIELD REGARDING DEVICE SETTINGS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP 17 MONTHS POST IMPLANT, THE GENERATOR WAS FOUND AT ELECTIVE REPLACEMENT INDICATOR (ERI). MEASURED DATA FOR THE DEVICE REVEALED HIGH CURRENT DRAIN.
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 | 5810 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |