BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2911755 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17072
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS PRODUCT WAS INSPECTED AND A HOLE IN THE ATRIUM TIP SEAL PLUG WAS OBSERVED. TESTING VERIFIED NORMAL ELECTRICAL FUNCTION. SETSCREW SEAL PLUGS ARE DESIGNED TO PERMIT SETSCREW WRENCH INSERTION WHILE PREVENTING BODY FLUIDS FROM ENTERING THE HEADER CAVITIES. ON OCCASION, WRENCH PENETRATION CAN DAMAGE A SEAL PLUG WHICH CAN LEAD TO ACCESSORY SENSING PATHWAYS AND POTENTIALLY RESULT IN OVERSENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A LEAD REPLACEMENT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD SETSCREW SEAL WAS NOTED TO BE SEVERELY COMPROMISED. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17749 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 4470| S606| 4137| 1291| 4088