FDA Adverse Event
Death
Summary report: N
UNIFY CRT-D
MDR report key: 3181077
·
Received June 20, 2013
Report
- Report Number
- 2938836-2013-02800
- Event Type
- Death
- Date Received
- June 20, 2013
- Date of Event
- November 5, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WITH A HISTORY OF VT AND VT ABLATIONS HAD A PERSISTENT VT EPISODE FROM WHICH THE PATIENT DID NOT SURVIVE. UPON INTERROGATION OF THE DEVICE, A LOSS OF BI-V CAPTURE THAT LED TO A DIAGNOSIS OF VT WAS OBSERVED. INAPPROPRIATE THERAPY WAS DELIVERED, BUT INDUCED THE RHYTHM INTO TRUE VT WHICH THE DEVICE PROPERLY SENSED, DIAGNOSED AND CARDIOVERTED THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280025 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3235-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |