FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D
MDR report key: 3090228
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01248
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 26, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- 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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC AFTER RECEIVING A PATIENT NOTIFIER. PSEUDO PSEUDOFUSION RESULTED IN FUNCTIONAL LOSS OF CAPTURE. NSLN EPISODES WERE OBSERVED. THE DEVICE WAS REPROGRAMMED AND PATIENT NOTIFIER FOR NSLN WAS DISABLED. THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192305 | QUADRA ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3265-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |