BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1852701 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14466
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 9, 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
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED. PENDING THE COMPLETION OF LAB ANALYSIS, THIS SECTION WILL BE UPDATED APPROPRIATELY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH DEVICE ANALYSIS WAS PERFORMED. THE DEVICE FUNCTIONED WITHIN ELECTRICAL SPECIFICATIONS DURING DETAILED ANALYSIS. BASED ON THE AVAILABLE INFORMATION, THE DEVICE EXCEEDED THE MINIMUM PREDICTED LONGEVITY. REVIEW OF MEMORY FOUND THE DEVICE WAS OPERATING AT THE UPPER THRESHOLD OF THE CALCULATED HYBRID BIN CURRENT, MINIMAL CHANGES TO THRESHOLDS, PACING RATE AND/OR LEAD IMPEDANCES RESULTED IN THE HYBRID CALCULATED BIN CURRENT INCREASING, WHICH RESULTED IN AN UNEXPECTED ELECTIVE REPLACEMENT TIME DECLARATION AND A ONE YEAR REDUCTION IN THE LONGEVITY REMAINING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED. AS A RESULT, BOSTON SCIENTIFIC CRM IS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE REOPENED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS EXPLANTED. PENDING THE RETURN AND COMPLETION OF LAB ANALYSIS, THIS SECTION WILL BE UPDATED APPROPRIATELY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE INDICATED A REMAINING LONGEVITY OF ONE YEAR. ONE MONTH LATER, THE DEVICE HAD THE TRIPPED ELECTIVE REPLACEMENT INDICATOR.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS DEVICE WAS EXPLANTED AS THE DEVICE DEPLETED RAPIDLY SINCE THE LAST DEVICE CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening 1290| (B)(4)| (B)(4)| (B)(4)