BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223584 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03598
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 6, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    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

    THE REPORTED NOISE WAS CONFIRMED. ANALYSIS FOUND THE OUTER INSULATION WAS ABRADED OPEN 43 CM TO 45 CM FROM THE HELIX END OBER THE IS-1 RING CABLE LUMEN. THE ETFE INSULATION OF ONE OF THE RING CABLES WAS ALSO ABRADED OPEN, EXPOSING THE CONDUCTOR WIRES INSIDE. BOTH INSULATION ABRASIONS WERE CAUSED BY FRICTION TO THE ICD CAN, WHICH GENERATES NOISE. FURTHER ANALYSIS FOUND AN INTTERNAL ABRASION, ALSO EXPOSING CABLE CONDUCTORS. CONTACT BETWEEN THE BARE RV CABLE CONDUCT- ORS AND THE SVC SHOCK COIL RESULTED IN A SPARK AND MELTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY, DUE TO NOISE ON THE LEAD. THE LEAD WAS 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 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention