FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 2984251
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00400
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- December 1, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT INAPPROPRIATE THERAPY WAS OBSERVED. INSULATION BREAK WAS NOTED IN TWO PLACES. LEAD REVISION WAS STOPPED DUE TO HEMORRHAGIC SHOCK ON THE SUBCLAVIAN WOUND, ALSO IT WAS NOTED THAT IT WAS IMPOSSIBLE TO REMOVE THE LEAD WHICH WAS STUCK TO ANOTHER LEAD. THE LEAD WAS CAPPED AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86768 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7022/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4). |