BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN

    MDR report key: 1871648 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18252
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 29, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE HEADER WAS COMPLETELY SEPARATED FROM THE DEVICE CASE AND THE FEED THROUGH WHICH CONNECT THE DEVICE CIRCUITRY TO THE HEADER CONNECTOR BLOCKS WERE FRACTURED. MICROSCOPIC ANALYSIS OF THE HEADER BOND CONNECTION AREA NOTED THE MEDICAL ADHESIVE WAS STILL ATTACHED TO THE HEADER. ALL TELEMETRY AND INTERROGATION OPERATIONS WERE NORMAL. HOWEVER, ELECTRICAL FUNCTIONS COULD NOT BE TESTED DUE TO THE DETACHED HEADER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THE DEVICE WAS TIGHT IN THE POCKET, AND THE HEADER WAS IN AN INFERIOR POSITION IN THE POCKET. THE DEVICE WAS ABLE TO BE MANIPULATED AND REMOVED FROM THE POCKET WITH FINGER PRESSURE. AS THE DEVICE WAS REMOVED FROM THE POCKET, THE HEADER CAME OFF THE DEVICE CASE. THE PATIENT WAS ASYSTOLIC FOR SEVERAL SECONDS UNTIL THE LEADS WERE REMOVED FROM THE DETACHED HEADER AND CONNECTED TO AN EXTERNAL PERMANENT PACEMAKER. THE PATIENT EXPERIENCED DIZZYNESS DUE TO THE ASYSTOLE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIDIAN IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1276

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 1276