FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR, DF4 CONNECTOR
MDR report key: 3101154
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01942
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- March 19, 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
- DC
- 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 AN ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A VIBRATORY ALERT. IT WAS OBSERVED THAT THE SENSING LATENCY ON THE FAR FIELD CHANNEL RESULTED IN THE NSLSN TRIGGER. THE DEVICE WASREPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202978 | FORTIFY ASSURA DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2257-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |