FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA DR CRT-D
MDR report key: 4153551
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16443
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- August 27, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT RECEIVED DELAYED THERAPY FOR VENTRICULAR TACHYCARDIA DUE TO THE DEVICE INAPPROPRIATELY DIAGNOSING THE ARRHYTHMIA AS BIGEMINY. SHOCKS WERE DISABLED IN VT-1 ZONE DUE TO POTENTIAL FOR EXCESSIVE SHOCKS TO TREAT PATIENTS PERSISTENT VT. THE PATIENT RECENTLY HAD AN UNSUCCESSFUL VT ABLATION AND ANOTHER ABLATION WAS SCHEDULED. THE DEVICE IS FUNCTIONING NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631472 | UNIFY ASSURA DR CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3357-40C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |