BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1863581 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15391
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    December 22, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S CRM RELIABILITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. INITIAL TESTING NOTED THAT THE DEVICE HAD NO TELEMETRY. THE CAUSE OF THE HIGH CURRENT RESULTING IN BATTERY DEPLETION AND INABILITY TO INTERROGATE THE DEVICE WAS A CRACKED COMPONENT. THE CRACKING OF THE CERAMIC MATRIX WAS CAUSED BY APPLIED STRESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND WILL BE ANALYZED. UPON ANALYSIS THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN EXPLANTED AND WILL BE RETURNED.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A FOLLOW UP IT WAS NOTE POSSIBLE TO INTERROGATE THIS PULSE GENERATOR (PG). A MAGNET WAS PLACED ON THE DEVICE WITH NO SUCCESS. NO PACING SPIKES OR PACING EVENTS WERE SEEN ON THE SURFACE ELECTROCARDIOGRAM. IT WAS NOTED THAT THIS PATIENT HAD AN UNDERLYING INTRINSIC RHYTHM THUS, NO ASYSTOLE WAS NOTED. IT WAS SUSPECTED THAT THE DEVICES BATTERY HAD DEPLETED, AND AN IMMEDIATE REPLACEMENT WAS RECOMMENDED. AT THIS TIME THIS DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE 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 1198

    Patients

    Seq Age Sex Outcome Treatment
    1