BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3211603 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-10307
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED INAPPROPRIATE THERAPY FOR AN ATRIAL TACHYCARDIA. THE DEVICE DELIVERED SHOCKS UNTIL THERAPY WAS EXHAUSTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE. THE TS CONSULTANT DISCUSSED PROGRAMMING OPTIONS TO PREVENT INAPPROPRIATE THERAPY DELIVERY. THE ICD REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309386 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 4470| 4469| 0292| E162| 1291