BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1955125 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00152
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 18, 2010
    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 Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    INSULATION DAMAGE WAS OBSERVED ON THE LEAD AT 37.2CM AND 38.8CM FROM THE HELIX TIP, CHARACTERISTIC OF LEAD FRICTION TO THE ICD CAN. THE SVC CABLES WERE EXPOSED IN BOTH LOCATIONS BUT NO ABRASION ON THE CABLES WAS FOUND. AN INSIDE OUT ABRASION WAS NOTED AT 9.3CM TO 9.8CM FROM THE HELIX TIP, EXPOSING THE RV CABLES, HOWEVER THE EFTE INSULATION WAS NORMAL. FURTHER ANALYSIS ON THE SVC SHOCK COIL FOUND INSIDE OUT ABRASION AT 18.5CM TO 20.2CM FROM THE HELIX TIP. THE ETFE INSULATION ON THE PROXIMAL CABLE WAS ALSO ABRADED. THIS COULD CAUSE THE OVERSENSING AS REPORTED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING WAS OBSERVED ON THE EGM, INDICATIVE OF A DAMAGED LEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention