BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1871501 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17277
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 1, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS EXPLANTED AND RETURNED. PENDING THE COMPLETION OF LAB ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH DEVICE ANALYSIS WAS PERFORMED. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. ANALYSIS OF THE DEVICE MEMORY INDICATED 1 RESET. THE LAST RESET REASON WAS AN ACCESS ERROR RESET. THE CAUSE OF THE ACCESS ERROR RESET WAS NOT DETERMINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR UNKNOWN REASONS. NO ALLEGATIONS WERE RECEIVED AGAINST THIS DEVICE. THIS EVENT WAS CREATED DUE TO THE INITIAL TESTING PERFORMED BY OUR POST MARKET QUALITY ASSURANCE LABORATORY. INITIAL TESTING NOTED A POSSIBLE PERFORMANCE ISSUE. THIS DEVICE IS PART OF THE INSIGNIA MICROCRYSTAL POPULATION DESCRIBED IN THE PHYSICIAN COMMUNICATION ON (B)(6) 2005.

    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 CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 1298| 1230| 4285| 4269