BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3921800 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12328
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD SHOCK LEAD IMPEDANCE OF 20 OHMS AND 0 OHMS AT IMPLANT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED TURNING OFF EQUIPMENT THAT COULD INTERFERE THE TEST. THE PHYSICIAN PERFORMED COMMANDED SHOCK AND GOT NORMAL RANGE WITH NEW PULSE GENERATOR IN BOTH TRIAD AND COIL TO CAN CONFIGURATION. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400441 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 4473| 4592| E051| N161| 0185