FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA CRT-D
MDR report key: 3791046
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10416
- Event Type
- Malfunction
- Date Received
- May 5, 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 Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED MYOPOTENTIAL OVERSENSING WAS OBSERVED RESULTING IN FALSE DETECTION OF NON-SUSTAINED LEAD NOISE. PROGRAMMING CHANGES WERE RECOMMENDED. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE CONSEQUENCES WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268039 | UNIFY ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3261-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |