FDA Adverse Event
Malfunction
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 2242837
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06252
- Event Type
- Malfunction
- Date Received
- September 11, 2011
- Date of Event
- July 21, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- 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 THE PATIENT PRESENTED TO THE HOSPITAL DUE TO INAPPROPRIATE SHOCKS CAUSED BY DOUBLE COUNTING ON T-WAVE. EGM REVEALED THE R-WAVES HAD DECREASED. THE DEVICE AND LEAD REMAIN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |