FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D, DF4 CONNECTOR
MDR report key: 3210731
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03434
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 25, 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 VT MAPPING AND ABLATION, NOISE WITH LOSS OF SENSING WERE OBSERVED. THE PHYSICIAN CONCLUDES THAT THE CATHETER WAS NOT RESPONSIBLE FOR THE NOISE AND IS EXTERNAL IN ORIGIN. DEVICE WAS PROGRAMMED TO NO PACING AND NO THERAPY, WITH EXTERNAL SUPPORT IN PLACE. ABLATION PROCEDURE CONCLUDED WITHOUT ANY OTHER ISSUES AND THE ICD RESTORED TO INITIAL CONFIGURATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310500 | UNIFY CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3235-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |