FDA Adverse Event
Death
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 2984551
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00433
- Event Type
- Death
- Date Received
- February 28, 2013
- Date of Event
- January 16, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- 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 EXPIRED. THE PHYSICIAN INQUIRED ABOUT WHETHER THE PATIENT DEATH WAS RELATED TO UNDERSENSING VF. UPON REVIEW OF INFORMATION, IT'S BELIEVED THAT THE UNDERSENSING IS ACTUALLY DUE TO A SMALL R-WAVE AT IMPLANT (1.4MV) AND THE HEART MAY HAVE ALREADY NEARLY STOPPED FUNCTIONING PRIOR TO VF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85646 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Death | (B)(4) |