BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3052524 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04675
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION FOUND MARKS ON THE DEVICE HEADER DUE TO EXPLANT BUT NO OTHER IRREGULARITIES. MICROSCOPIC VISUAL INSPECTION FOUND MARKS ON THE HEADER DUE TO EXPLANT BUT NO OTHER IRREGULARITIES. THE HEADER IS COMPLETELY INTACT AND THE LEAD WAS FULLY INSERTED. FURTHER ANALYSIS FOUND THE THAT RIGHT VENTRICULAR SPRINT CONTACT IS OUT OF SPECIFICATION. THE OUT OF SPECIFICATION SPRING CONTACT COULD CAUSE THE REPORTED CLINICAL OBSERVATIONS AND POTENTIALLY NOT DELIVERY THERAPY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RIGHT VENTRICULAR LEAD REVISION TOOK PLACE DUE TO INAPPROPRIATE SHOCK THERAPY AND OVERSENSING. DUE TO THE PATIENTS YOUNG AGE IT WAS DECIDED TO USE A DF-4 PLUG THUS THIS DEVICE WAS ALSO REPLACED. THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155132 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1