FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA CRT-D, DF4 CONNECTOR
MDR report key: 3210570
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03470
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 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
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. POST PACED T WAVE OVERSENSING WAS NOTED VIA STORED EGM. THE PATIENT DID NOT RECEIVE THERAPY. REPROGRAMMING CHANGES WERE RECOMMENDED, HOWEVER, THE PHYSICIAN DOES NOT WANT TO PERFORM ANY FURTHER TESTING ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311521 | UNIFY ASSURA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3257-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |