BEUDAMED
    FDA Adverse Event Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1010773 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-01024
    Date Received
    March 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FRACTURE WAS CONFIRMED IN THE LABORATORY. VISUAL ANALYSIS FOUND INSULATION ABRASION AT 6.4CM, 7.8CM, 25.6CM, AND 54CM FROM THE CONNECTOR PIN. THE PROXIMAL COIL WAS FRACTURED AT 7.8CM FROM THE CONNECTOR PIN. SEM PHOTOGRAPHS CONFIRMED ALL WIRES OF THE PROXIMAL COIL WERE FRACTURED. THE DAMAGES FOUND ON THE LEAD WERE CONSISTENT WITH FRICTION TO THE ICD CAN.

    Description of Event or Problem · 1

    ALLEN MEDICAL RECEIVED A REPAIR REQUEST FOR A BROKEN HEAD POSITIONER WITH A CRACKED CRADLE. THE UNIT WAS RECEIVED FOR EVAL. THERE WAS NO PT INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1572/65

    Patients

    Seq Age Sex Outcome Treatment
    1