BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2052881 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03818
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 16, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, PACING AND SENSING FUNCTIONALITY WERE CONFIRMED TO BE APPROPRIATE. A VISUAL INSPECTION NOTED MEDICAL ADHESIVE WAS STILL ATTACHED TO THE HEADER AND WAS ADEQUATE. AN X-RAY REVEALED THE HEADER WIRES WERE NOT FRACTURED. AS A RESULT, CRITICAL THERAPY REMAINED AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS BEING EXPLANTED DUE TO A SYSTEM UPGRADE. DURING THE PROCEDURE, THE HEADER JUST ABOUT FELL OFF WHEN THE DEVICE WAS REMOVED FROM THE POCKET. NO ROUGH HANDLING WAS NOTED WHEN THE DEVICE WAS REMOVED. THE DEVICE DID NOT INDICATE ANY NOISY EPISODES OR OUT OF RANGE LEAD DIAGNOSTICS. NO DIFFICULTY WAS EXPERIENCED WHEN REMOVING THE LEADS FROM THE HEADER. THE PATIENT WAS NOT DEPENDENT AND THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR (B)(4)| 1297| (B)(4)