FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D
MDR report key: 3090289
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01227
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 26, 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 THE PATIENT EXPERIENCED NEAR SYNCOPE. PAUSES WERE NOTED ON THE ECG. PROVOCATIVE TEST AND POCKET MANIPULATION WERE PERFORMED BUT NO OVERSENSING WAS DETECTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193025 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3235-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |