FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR
MDR report key: 3220342
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04472
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 21, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 A PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A NOTIFIER FOR NONSUSTAINED LEAD NOISE. REVIEW OF EPISODES SHOWED A SENSING LATENCY BETWEEN THE FAR FIELD AND NEAR FIELD CHANNELS, WHICH TRIGGERED THE NON-SUSTAINED LEAD NOISE EPISODES. PROGRAMMING CHANGES WERE RECOMMENDED. DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320496 | FORTIFY ASSURA DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2257-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |