FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA VR, DF4 CONNECTOR
MDR report key: 3210687
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03360
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 8, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT PRESENTED TO THE CLINIC AFTER EXPERIENCING A VIBRATORY ALERT FOR NON-SUSTAINED RV LEAD NOISE. UPON REVIEW OF THE STORED EGM, IT WAS NOTED THAT NON SUSTAINED LEAD NOISE WAS TRIGGERED DUE TO SENSING LATENCY IN THE DISCRIMINATOR CHANNEL. PROGRAMMING CHANGES WERE RECOMMENDED AND THE PATIENT NOTIFIER ALERT WAS TURNED OFF. THE DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION NOTES THE DEVICE WAS SUCCESSFULLY REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309554 | FORTIFY ASSURA VR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1257-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |