FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D
MDR report key: 3210751
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03481
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 8, 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
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED UPON RECEIPT OF THE DEVICE. THE DEVICE HAD A POWER-ON RESET DURING WHICH WAS FOLLOWED BY SOSD DETECTION. THE DEVICE WAS TESTED ON THE BENCH AND OUTPUT CIRCUIT DAMAGE WAS NOTED. THE ROOT CAUSE OF THE POWER-ON RESET AND OUTPUT CIRCUIT DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING NORMAL DEVICE CHANGE OUT PROCEDURE, THE DEVICE WENT INTO BVVI AFTER DFT TESTING. THE DEVICE WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310617 | 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 | 54 YR | 1580/60 RD10471 |