BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX

    MDR report key: 1953742 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24751
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 9, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    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, MICROSCOPIC VISUAL INSPECTION OF THE HEADER AND THE SEAL PLUGS REVEALED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY AND FUNCTIONED AS DESIGNED. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. 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 AND ATRIAL CHANNELS OF THE OUTER SEAL RINGS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THIS ELECTIVE REPLACEMENT PROCEDURE, THE ASSOCIATED LEADS WERE STUCK IN THE DEVICE HEADER. BOTH LEADS WERE REMOVED SUCCESSFULLY AND REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1270

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR S603| 4034| 4063| 1270