BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUS VDD

    MDR report key: 2042359 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02227
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 17, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY WITH THE SEVERED PROXIMAL PORTION OF THE RELATED LEAD IN THE HEADER. VISUAL INSPECTION OF THE PACEMAKER HEADER REVEALED THAT ALL SETSCREWS WERE FULLY RETRACTED. THE SEAL PLUGS HAD BEEN REMOVED. DURING ANALYSIS, THE LEAD PORTION WAS REMOVED FROM THE HEADER WITH NORMAL FORCE. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY AND FUNCTIONED AS DESIGNED. THE DEVICE HEADER WAS THEN DISASSEMBLED AND BOTH THE INNER AND OUTER SEALS WERE INSPECTED. EVIDENCE OF SILICONE TO SILICONE BONDING WAS FOUND IN THE SEAL RINGS OF BOTH THE ATRIAL AND VENTRICULAR LEAD PORTS. ANALYSIS CONCLUDED THE SILICONE TO SILICONE BONDING LIKELY CONTRIBUTED TO THE CLINICAL OBSERVATION OF LEAD REMOVAL DIFFICULTY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, DIFFICULTY WAS ENCOUNTERED REMOVING THE RELATED LEAD FROM THE DEVICE HEADER. THE LEAD COULD NOT BE SUCCESSFULLY REMOVED, AND THE LEAD WAS CUT AND SURGICALLY ABANDONED. THE PATIENT WAS HOSPITALIZED AS A NORMAL PART OF THE REPLACEMENT PROCEDURE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUS VDD IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1320

    Patients

    Seq Age Sex Outcome Treatment
    1