FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA CRT-D
MDR report key: 3801311
·
Received May 8, 2014
Report
- Report Number
- 2938836-2014-10989
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- March 28, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE NOTED AN OVER-CURRENT DETECTION ALERT AND INDICATED THAT THE BACKUP VVI WAS DUE TO A POWER-ON RESET. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND. THE RESET WAS NOT REPRODUCED. THE CAUSE OF THE POWER-ON RESET COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, UPON DFT TESTING, IT APPEARED TO DELIVER THERAPY, BUT DID NOT CONVERT THE RHYTHM. THE PATIENT WAS EXTERNALLY CARDIOVERTED AND THE DEVICE WENT INTO BACKUP VVI. THE DEVICE WAS REPLACED. THE PATIENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279056 | UNIFY ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3257-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | (B)(4) |