FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA DR CRT-D
MDR report key: 4173848
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16708
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- August 12, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT PRESENTED FOR FOLLOW UP AFTER RECEIVING A VIBRATORY ALERT FOR OVERSENSED NOISE. NOISE WAS NOT REPRODUCED WITH MOVEMENT AND MANIPULATION OF THE DEVICE. IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE OVERSENSING AND NOISE. THE NOTIFIER WAS TURNED ON IN THE CASE OF ANOTHER ALERT FOR NOISE SHOULD BE TRIGGERED. THE PATIENT WAS SEEN FOR A SUBSEQUENT FOLLOW-UP VISIT, AND THERE HAVE BEEN NO FURTHER ALERTS OR PROBLEMS. THE PHYSICIAN NOTED THAT EVERYTHING WAS WORKING APPROPRIATELY. NORMAL FOLLOW-UP WILL CONTINUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654486 | UNIFY ASSURA DR CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3361-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |