BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY II

    MDR report key: 1861141 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15453
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    October 25, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Removal / Correction Number
    Z-875-03 TO Z-897-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR ANALYSIS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH DEVICE ANALYSIS WAS PERFORMED. IT WAS NOTED THAT THE DEVICE WAS RETURNED WITH A DETACHED HEADER. VISUAL INSPECTION NOTED AN ADEQUATE AMOUNT OF MEDICAL ADHESIVE STILL ATTACHED TO THE HEADER. A VISUAL INSPECTION OF THE HEADER NOTED NO ANOMALIES. THE DEVICE HEADER WAS DISASSEMBLED AND EVIDENCE OF SILICONE TO SILICONE BONDING WAS FOUND IN BOTH INNER SEALS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION SHOWS MEDICAL ADHESIVE WAS STILL ATTACHED TO HEADER, AND WAS ADEQUATE. THE DEVICE HEADER WAS CHECKED PER LEAD GAUGE PINS, AND PASSED. THE DEVICE WAS CHECKED WITH IS-1 LEAD AND FIT WAS NORMAL. A CLOSER VISUAL LOOK AT THE HEADER, UNDER HIGH POWER MICROSCOPE SHOWED NO IRREGULARITIES IN LEAD BARRELS, AND ALL SETSCREWS MOVED FREELY. THE DEVICE HEADER WAS DISASSEMBLED AND BOTH INNER AND OUTER SEALS WERE INSPECTED. THERE WAS EVIDENCE OF SILICONE TO SILICONE BONDING WERE FOUND IN BOTH INNER SEALS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS BEING EXPLANTED FOR NORMAL BATTERY DEPLETION. DURING THE CHANGEOUT PROCEDURE, THE RIGHT ATRIAL LEAD WAS STUCK IN THE HEADER. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1286

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 1286| 4269| 4285| 0950| S603| 5076