BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY

    MDR report key: 1851800 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14226
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    December 29, 2009
    Report Date
    July 12, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-875/897-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, PRE-DECONTAMINATION TESTING NOTED ALL SET SCREWS WERE FREE. THE VENTRICULAR SEAL PLUGS WERE MISSING AND THE VENTRICULAR RING CAP WASHER WAS BENT AS WELL AS THE TIP. ADDITIONAL TESTING PERFORMED NOTED AN ACCESS ERROR RESET OCCURRED, HOWEVER THIS IS NORMAL. VISUAL INSPECTION OF THE DEVICE HEADER NOTED NO ANOMALIES. THE HEADER WAS THEN DISASSEMBLED AND BOTH THE INNER AND OUTER SEALS WERE INSPECTED. EVIDENCE OF SILICONE TO SILICONE BONDING WERE FOUND IN BOTH THE INNER AND OUTER SEALS. TECHNICIANS ALSO NOTED THAT BOTH THE VENTRICULAR CAPTURE WASHERS WERE DISTENDED. THIS RESULTS FROM A SETSCREW BEING BACKED OUT TOO FAR AND WITHOUT A CORRECT OR WORKING WRENCH. THIS CAUSES THE SETSCREW TO STICK IN THE CAPTURE WASHERS. NO FURTHER TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THIS NORMAL PACEMAKER REPLACEMENT PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE SET SCREWS FROM THE ORIGINAL DEVICE. THE SET SCREWS WERE ABLE TO BE LOOSENED WHEN APPLYING MINERAL OIL AND USING THE 20 TO 30 DEGREE ANGLE TECHNIQUE DESCRIBED IN THE SALES SOURCE. IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD WOULD NOT RELEASE FROM THE HEADER, HOWEVER ONCE THE PHYSICIAN USED A BONE CUTTER TO CUT THE BACK OF THE HEADER, THE LEAD WAS ABLE TO BE RELEASED. THERE WAS NO DAMAGE SUSTAINED TO THE LEAD. BOTH LEADS WERE SUCCESSFULLY PLACED IN THE NEW DEVICE AND THE PATIENT WAS SENT HOME WITH NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1274

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 1274| 4054| S603| 4035