FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 2242754
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06265
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- July 5, 2011
- 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 ANALYSIS FOUND INSULATION ABRASION CONSISTENT WITH FRICTION TO THE ICD CAN. ONE OF THE RV CONDUCTOR CABLES WAS BROKEN AND MELTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC WITH SHOCKS. THE DEVICE WAS INTERROGATED AND DISPLAYED POSSIBLE PROBLEM IN THE HV CIRCUIT. ANALYSIS OF THE ICD SHOWED EVIDENCE OF A HV ARC BETWEEN THE ICD AND DAMAGED LEAD.
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 | 7022/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |