FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR
MDR report key: 3220143
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04471
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 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
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).
Description of Event or Problem · 1
NEW INFORMATION RECEIVED INDICATED THE DEVICE WAS REPROGRAMMED WITH NO FURTHER ISSUES.
Description of Event or Problem · 1
IT WAS REPORTED NON-SUSTAINED LEAD NOISE WAS OBSERVED VIA A REMOTE MONITORING SYSTEM. AFTER REVIEWING THE ELECTROGRAMS, NO LEAD NOISE WAS DETECTED AND VENTRICULAR EVENTS WERE UNDERSENSED. REPROGRAMMING CHANGES WERE RECOMMENDED. THE PATIENT WILL BE MONITORED AT THE NEW FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321064 | FORTIFY ASSURA DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2257-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |