BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1945586 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19953
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    November 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE PACEMAKER HAS NOT BEEN RETURNED. IF THIS PACEMAKER SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS EVENT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY THE DEVICE FUNCTIONED WITHIN ELECTRICAL SPECIFICATION DURING DETAILED ANALYSIS. THE DEVICE CASING DOES SHOW ELECTRO-CAUTERY MARKINGS AND MEMORY SHOWS 10 SYSTEM RESETS OCCURRING AT EXPLANT. THE MOST PROBABLE CAUSE OF THE OBSERVATION NOTED IN THE FIELD OF INHIBITED PACING WAS ELECTRO-CAUTERY. THE ELECTRO-CAUTERY RESULTED IN HARDWARE RESETS BY THE DEVICE, WHEN THE DEVICE CYCLES THROUGH RESET STATE, PACING IS INHIBITED DURING THE RESET CYCLE. THE BATTERY STATUS DISCREPANCY IS DUE TO THE DEVICE CYCLING THROUGH A SYSTEM RESET. THE DEVICE MEETS SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRV RECEIVED INFORMATION THAT DURING A RECENT ROUTINE DEVICE CHANGE OUT PROCEDURE, THIS DEVICE WAS PROGRAMMED TO SOO SO CAUTERY COULD BE USED. DURING THE USE OF CAUTERY, IT WAS NOTED THAT THE DEVICE EXHIBITED PACING INHIBITION. THE DEVICE WAS THEN PROGRAMMED TO VOO AND THE PACING RESUMED TO NORMAL FOR THE REMAINDER OF THE SURGERY. THE DEVICE WAS INTERROGATED ONCE EXPLANTED AND SHOWED A BATTERY STATUS OF GREATER THAN 5 YEARS REMAINING WITH A MAGNET RATE OF 90 BMP INDICATING CONFLICTING BATTERY STATUS MEASUREMENTS FROM PRIOR TO EXPLANT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1194

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Life Threatening 1194| 4470