FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1830927
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03252
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- July 29, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS FOUND INSULATION ABRASIONS AT 21.2CM, 24CM, 25CM AND 26CM FROM THE CONNECTOR PIN. ONE OF THE RV ETFE CABLES WAS ABRADED AT 26CM FROM THE CONNECTOR PIN. THE REPORTED SENSING ANOMALY ROOT CAUSE COULD NOT BE DETERMINED. THE DAMAGE FOUND IS CONSISTENT WITH FRICTION TO THE ICD CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING INAPPROPRIATE HV THERAPY. REVIEW OF THE EPISODES SHOWED NOISE ON THE LEAD. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |