BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR MAX

    MDR report key: 1852651 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14452
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    June 14, 2010
    Report Date
    July 15, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Removal / Correction Number
    Z-1032-05 THRU Z-1039-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER IS SCHEDULED TO BE RETURNED FOR ANALYSIS. THIS EVENT WILL BE UPDATED WHEN THE DEVICE IS RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THIS PACEMAKER REPLACEMENT PROCEDURE, THE VENTRICULAR LEAD COULD NOT BE REMOVED FROM THE DEVICE HEADER. MINERAL OIL WAS USED WITH NO SUCCESS. THE PHYSICIAN PULLED WITH MORE FORCE ON THE LEAD AND UNRAVELED THE COIL. THE LEAD WAS CUT AND SURGICALLY ABANDONED. A NEW DEVICE AND VENTRICULAR LEAD WERE SUCCESSFULLY 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 1170

    Patients

    Seq Age Sex Outcome Treatment
    1