FDA Adverse Event
Injury
Summary report: N
UNIFY QUADRA CRT-D, DF4 CONNECTOR
MDR report key: 3080255
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-01017
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- March 4, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS
- 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 PRESENTED TO THE CLINIC FOR FOLLOW UP AFTER EXPERIENCING INAPPROPRIATE ATP AND HV THERAPY FOR ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RESPONSE. FURTHER REVIEW SHOWED THE DEVICE FUNCTIONED AS PROGRAMMED. PHYSICIAN REPROGRAMMED THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180954 | UNIFY QUADRA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3249-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |