FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF4 CONNECTOR
MDR report key: 3210452
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03519
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 4, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF THE DEVICE IN BACKUP VVI MODE WAS CONFIRMED IN THE LABORATORY. THE BACKUP VVI MODE WAS DUE TO CONSECUTIVE DEVICE RESETS, WHICH WERE CAUSED BY BAD MEMORY OPERATIONS.
Description of Event or Problem · 1
IT WAS REPOTED THAT PRIOR TO IMPLANT, THE DEVICE WAS INTERROGATED AND FOUND TO BE IN BACKUP VVI MODE. THE DEVICE WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311016 | QUADRA ASSURA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3267-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |