BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1830700 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03317
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    May 25, 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
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS CONFIRMED THE NOISE AS REPORTED IN THE FIELD. AN INSULATION ABRASION WAS NOTED AT 18CM FROM THE CONNECTOR END. THE IS-1 PROXIMAL METAL CABLE WAS EXPOSED. THIS WOULD ACCOUNT FOR THE REPORTED NOISE. ANOTHER ABRASION WAS NOTED AT 13.4CM FROM THE CONNECTOR END. THE LOCATIONS OF THE ABRASIONS ARE CONSISTENT WITH FRICTION TO THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE RV AND ATRIAL LEADS. NO THERAPIES WERE DELIVERED. LEAD INSULATION DAMAGE WAS OBSERVED DURING THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention (B)(4)