FDA Adverse Event
Malfunction
Summary report: N
UNIFY QUADRA CRT-D, DF4 CONNECTOR
MDR report key: 3080247
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-01019
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- November 1, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- NA
- 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 ROUTINE FOLLOW UP, DEVICE INTERROGATION REVEALED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY IN (B)(6) 2012 FOR ATRIAL FIBRILLATION WITH FAST VENTRICULAR CONDUCTION. THE PHYSICIAN INCREASED THE BETA BLOCKER DRUG THERAPY. PATIENT CONDITION IS GOOD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183301 | UNIFY QUADRA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3251-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |