BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1950414 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22507
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    May 17, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    (B)(6) MONTHS LATER THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION (NBD). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A SYNCOPAL EPISODE OF UNKNOWN ETIOLOGY AND WAS ADMITTED TO THE HOSPITAL. UPON DEVICE INTERROGATION, THE FIELD REPRESENTATIVE ENCOUNTERED DIFFICULTY DUE TO A DEEP IMPLANT, HOWEVER WAS FINALLY SUCCESSFUL. THE DEVICE MEMORY WAS SEARCHED FOR STORED ARHTHMIA EPISODES AND ONE VENTRICULAR TACHYCARDIA EPISODE WAS FOUND, HOWEVER WAS FROM TWO MONTHS PRIOR. SOME TELEMETRY NOISE WAS OBSERVED BUT WAS THOUGHT TO BE RELATED TO THE DEEP PACEMAKER IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening (B)(4)| (B)(4)| MISMATCH