BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR MAX II

    MDR report key: 1853970 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-18934
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    April 26, 2010
    Report Date
    July 21, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-875/897-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS PACEMAKER'S PACE, SENSE AND TELEMETRY OPERATIONS WERE FOUND TO BE NORMAL BASED UPON A SERIES OF DIAGNOSTIC TESTS. ANALYSIS FOUND THAT THE DEVICE SETSCREWS MOVED FREELY WITH NO BINDING AND AN IS-1 LEAD WAS ABLE TO FIT INTO THE DEVICE HEADER WITH NO ISSUES. THE DEVICE HEADER WAS EXAMINED UNDER HIGH POWER MICROSCOPE WHERE A HOLE IN THE ATRIAL RING SEAL PLUG WAS OBSERVED. IT WAS ALSO NOTED THAT THE ADHESIVE AND THE REST OF THE SEAL PLUGS APPEARED NORMAL AND THE HERMETIC SEAL APPEARED TO BE INTACT. UPON INITIAL VISUAL EXAMINATION, BODY FLUID CONTAMINATION WAS NOTED THROUGHOUT THE ATRIAL LEAD BARREL AND SET BLOCKS. FURTHER EXAMINATION SHOWED THAT THE ATRIAL RING SET SCREW AND THE SET BLOCK HAD MUCH MORE BODY FLUID CONTAMINATION THAN WAS INITIALLY OBSERVED. ANALYSIS CONCLUDED THAT THE HOLE IN THE ATRIAL RING SEAL PLUG ALLOWED BODY FLUID CONTAMINATION INTO THE SETSCREW AREA. THE ANALYSIS TECHNICIAN NOTED THAT BODY FLUID CONTAMINATION COULD HAVE INHIBITED PROPER SETSCREW OPERATION, HOWEVER NO PROBLEMS WERE NOTED DURING LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. DURING THE EXPLANT PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE LEAD FROM THE DEVICE HEADER, THE RIGHT ATRIAL (RA) LEAD UNRAVELED FROM THE TERMINAL PIN TO JUST ABOVE THE RING. THIS LEFT THE WIRE ON THE LEAD EXPOSED. THE PHYSICIAN BELIEVES HE LOOSENED BOTH OF THE ATRIAL SET SCREWS ADEQUETLY. THERE IS CONCERN THAT THE RA SET SCREWS DID NOT FUNCTION APPROPRIATELY. THE PORTION OF THE RA LEAD THAT UNRAVELED WAS EXPLANTED AND THE OTHER PORTION WAS SURGICALLY ABANDONED. A NEW RA LEAD WAS NOT IMPLANTED IN THE PATIENT DUE TO ATRIAL FIBRILLATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND A PORTION OF THE LEAD WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1280

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4285| 4053| S601| 1280