BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1945741 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20680
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    October 12, 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
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, INTERROGATION WITH A ZOOM PROGRAMMER WAS UNSUCCESSFUL, AND REVIEW OF DEVICE MEMORY NOTED THAT MULTIPLE RESETS HAD OCCURRED. THE RESETS INDICATE THAT THE INTERNAL CLOCK (A CRYSTAL TIMING COMPONENT) HAD CEASED FUNCTIONING ON MORE THAN ONE OCCASION. THE PACEMAKER WAS THEN SUBJECTED TO THOROUGH TESTING, AT WHICH TIME THE PACEMAKER CASE WAS OPENED. THE CRYSTAL OSCILLATOR COMPONENT, WHICH IS REQUIRED FOR ESSENTIAL PACING AND SENSING FUNCTIONS, WAS THEN REMOVED FROM THE DEVICE HYBRID. FURTHER TESTING REVEALED THE PRESENCE OF FOREIGN MATERIAL, WHICH WAS A RESIDUE OF THE MANUFACTURING PROCESS FOR THIS COMPONENT. EXTENSIVE ANALYSIS HAS DETERMINED THAT THESE PARTICLES CAN LODGE BETWEEN THE CRYSTAL TINES, AND/OR BETWEEN THE CERAMIC PACKAGE AND THE CRYSTAL TINES, CAUSING CRYSTAL OSCILLATION TO STOP. IF OSCILLATION CEASES, TELEMETRY AND PACING ARE NO LONGER SUPPORTED. THE MICROSCOPIC PARTICLES OBSERVED WITHIN THE CRYSTAL TIMING COMPONENT IN THIS DEVICE ARE CONSISTENT WITH THE FAILURE MODE 1 POPULATION DESCRIBED IN THE PRODUCT ADVISORY COMMUNICATION CONVEYED TO PHYSICIANS IN (B)(6), 2005.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY RECEIVED THIS IMPLANTABLE PACEMAKER WITH NO FIELD ALLEGATIONS. DEVICE MEMORY WAS REVIEWED INDICATING A POSSIBLE PRODUCT PERFORMANCE ISSUE. THEREFORE, THIS DEVICE HAS BEEN FORWARDED FOR DETAILED ANALYSIS. NO ADVERSE PATIENT EFFECTS REPORTED WITH THE RETURN OF THIS DEVICE.

    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 94 YR S603| 4087| 4086| 1298