BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3223518 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10231
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 5, 2013
    Report Date
    October 7, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. IT WAS ALSO REPORTED THAT A NOISE WAS NOTED ON PRESENTING ELECTROGRAM (EGM) BUT THERE WAS NO OVERSENSING . BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLE-SHOOTING AND TRYING DIFFERENT CONFIGURATIONS. TS FURTHER SUGGESTED DOING A COMMANDED SHOCK TEST TO HAVE THE MOST ACCURATE REPRESENTATION OF TRUE IMPEDANCE. ADDITIONAL INFORMATION WAS RECEIVED THAT A SURGICAL INTERVENTION WAS DONE TO RESOLVE THE ISSUE AND THE CAUSE OF NOISE WAS NOT DETERMINED. THE RV LEAD, THAT WAS SUSPECTED TO BE COMPROMISED, WAS SURGICALLY ABANDONED. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS OVER THREE YEARS LATER FOR AN UNRELATED ISSUE DOCUMENTED IN REPORT 2124215-2016-14331.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323948 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 4543| 4087| N161| E102