BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1043474 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33163
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 5, 2008
    Report Date
    October 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SR SHORTENED THE AV DELAY AND INCREASED THE LOWER RATE LIMIT TO CORRECT THE PATIENT SYMPTOMS. AS OF THIS DATE, THE PACEMAKER REMAINS IN SERVICES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO OUR COMPANY, THE EVENT WILL BE REOPENED AND UPDATED AS NECESSARY. TWO YEARS LATER THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND RETURNED. THE DEVICE IS CURRENTLY IN ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY ACCORDING TO ITS PERFORMANCE SPECIFICATIONS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS BSC SALES REPRESENTATIVE (SR) CALLED TECHNICAL SERVICES (TS) REPORTING THIS PATIENT WAS HAVING MANY SUDDEN BRADY RESPONSE (SBR) EPISODES WITH LIGHTHEADEDNESS. TS SUGGESTED SHORTENING THE ATRIAL VENTRICULAR (AV) DELAY TO INCREASE VENTRICULAR PACING AND SUGGESTED THIS COULD BE A NEUROLOGICAL ISSUE AND DISCUSSED OBTAINING AN ECHOGRAM. FURTHER INFORMATION FROM THE SR INDICATED THIS PATIENT DID EXPERIENCE SYNCOPAL EPISODES. THE SR STATED THEY SHORTENED THE AV DELAY AND INCREASED THE PATIENT'S LOWER RATE LIMIT TO CORRECT THE PATIENT SYMPTOMS. THE SR NOTED THE PHYSICIAN BELIEVES THIS CASE TO BE A NEUROLOGICAL ISSUE AND NOT DEVICE RELATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention