BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3904173 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-07977
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    October 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THROUGH FURTHER INVESTIGATION IT APPEARED THAT THE RF TELEMETRY WAS INTERMITTENT, HOWEVER ALL INDUCTIVE TELEMETRY WAS GOOD. THE DEVICE CASE WAS REMOVED. INTERNAL VISUAL INSPECTION FOUND NO IRREGULARITIES. ANALYSIS FOUND THAT THE RF MODULE WAS CAUSING THE INTERMITTENT RF COMMUNICATION, THIS WAS CONFIRMED BY DESIGN ENGINEERS AFTER HYBRID TESTING WAS COMPLETE. ANALYSIS CONFIRMED THE ISSUE FROM THE FIELD.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ATTEMPTED AND NOT IMPLANTED AS THE PHYSICIAN WAS UNABLE TO ESTABLISH TELEMETRY WITH THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382270 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E160

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 0293| E160