BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY II

    MDR report key: 1864096 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15914
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-875/897-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE HEADER WAS SEPARATED FROM PACEMAKER CASE AND ELECTRICAL TESTING WAS UNABLE TO BE PERFORMED. MICROSCOPIC VISUAL INSPECTION OF THE HEADER AND THE SEAL PLUGS REVEALED NO ANOMALIES. 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 VENTRICULAR CHANNEL OF THE INNER SEAL RINGS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A ROUTINE PACEMAKER REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION, A SET SCREW WAS REPORTEDLY STUCK AND THE CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS FOUND STUCK IN THE HEADER. THE PHYSICIAN USED A BONE CUTTER TO BREAK OPEN THE DEVICE HEADER AND FREE THE LEAD. THE RV LEAD WAS THEN SUCCESSFULLY INSERTED INTO A NEW PACEMAKER AND TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 47 YR 4285| S601| 4244| 1286