BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3050056 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05506
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 23, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    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. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A LOW AND HIGH OUT OF RANGE SHOCKING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THIS DEVICE WAS EXPLANTED DUE TO AN UNRELATED PRODUCT PERFORMANCE ISSUE WHICH HAS BEEN REPORTED IN REPORT # 2124215-2016-03720. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153393 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR T167| E163| 4469| 1861