BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3212669 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08943
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS AND NOISE. IN ADDITION, VARIABLE SHOCK IMPEDANCE MEASUREMENTS WERE DISPLAYED INCLUDING SOME HIGH OUT OF RANGE MEASUREMENTS. IT WAS THOUGHT THERE WAS LEAD SUBCLAVIAN CRUSH OR AN INSULATION BREACH. A REVISION PROCEDURE WAS PERFORMED. UPON REMOVAL, VISUAL INSPECTION DID NOT REVEAL ANY INSULATION ISSUE; HOWEVER IT WAS THOUGHT THERE MIGHT BE AN INSULATION ISSUE AT THE PROXIMAL END NEAR THE CLAVICLE. THE LEAD WAS REPLACED SUCCESSFULLY AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DID NOT RESULT IN INAPPROPRIATE SHOCKS OR A LOSS OF CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312307 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1