BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1875034 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19022
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A LOOSE HEADER. ALTHOUGH EVIDENCE INDICATES EXTERNAL STRESS MAY HAVE BEEN A FACTOR IN CAUSING THE HEADER TO BECOME LOOSE, THE ROOT CAUSE OF THE ABNORMALITY WAS ISOLATED TO INSUFFICIENT BONDING BETWEEN THE MEDICAL ADHESIVE AND THE TITANIUM CASING. PACING, SENSING, AND SHOCKING FUNCTIONS WERE VERIFIED PER ELECTRICAL TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE ROUTINE DEVICE REPLACEMENT PROCEDURE, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS NOTED TO HAVE A LOOSE HEADER; THE CONNECTOR BLOCK APPEARED SEPARATED FROM THE DEVICE. ALL DEVICE MEASUREMENTS WERE WITHIN NORMAL LIMITS AND CRITICAL THERAPY WAS AVAILABLE THROUGHOUT THE IMPLANT LIFE OF THE DEVICE. THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CLONMEL IRELAND 1860

    Patients

    Seq Age Sex Outcome Treatment
    1 Other