FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D
MDR report key: 3102517
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-02001
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- March 11, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FOLLOW-UP, THE DEVICE WAS FAR-FIELD OVERSENSING ON THE ATRIAL LEAD. THE PATIENT DID NOT RECEIVE UNANTICIPATED THERAPY, AND OVERSENSING WAS ALSO NOTED ON STORED EGM. IT WAS RECOMMENDED TO REPROGRAM THE DEVICE. THE DEVICE REMAINS IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204376 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3231-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |