FDA Adverse Event
Injury
Summary report: N
FORTIFY VR, DF-4 CONNECTOR
MDR report key: 3220317
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04426
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- April 11, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. BASED ON THE AVAILABLE PARAMETER AND USAGE INFORMATION, A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT OVER A PERIOD OF 7 MONTHS, THE BATTERY VOLTAGE SHOWED A SIGNIFICANT DECREASE. NO REASONS FOR THE ACCELERATED DEPLETION WERE IDENTIFIED. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319621 | FORTIFY VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1233-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |