BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2984269 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00391
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    September 28, 2012
    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

    INTERNAL INSULATION ABRASIONS WERE FOUND UNDER THE RV SHOCK COIL AT 5.6-5.7CM AND BETWEEN 6.1-6.6CM FROM THE HELIX END. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. AN EXTERNAL INSULATION ABRASION WAS NOTED AT 46.5-46.6CM FROM THE HELIX END, CONSISTENT WITH FRICTION TO THE ICD CAN. THE ETFE COAT ING WAS INTACT AT THIS LOCATION. AN EXTERNAL INSULATION ABRASION WAS FOUND AT 12.5-12.9CM FROM THE CONNECTOR END, CONSISTENT WITH FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED AT THIS LOCATION. THIS DAMAGE COULD CAUSE THE REPORTED INAPPROPRIATE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT RECEIVED INAPPROPRIATE THERAPY. DEVICE WAS EXPLANTED. PATIENT'S CONDITION IS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85630 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7002/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1