FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR
MDR report key: 3090198
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01192
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 4, 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 THE DEVICE WAS INTERMITTENTLY UNDERSENSING. IT WAS RECOMMENDED TO CHANGE SENSE/PACE VECTOR. THE DEVICE REMAINS IMPLANTED AND WILL BE MONITORED.
Description of Event or Problem · 1
CLARIFICATION OF EVENT: MISMATCH BETWEEN THE NEAR FIELD AND FAR FIELD CHANNELS RESULTED IN FALSE NON SUSTAINED LEAD NOISE. IT WAS RECOMMENDED TO REPROGRAM THE FAR-FIELD VECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192059 | FORTIFY ASSURA DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2257-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |