BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX II

    MDR report key: 2042444 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01183
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE EXPERIENCED A HEART RATE IN THE 20'S AND A SYNCOPAL EPISODES. THE PATIENT WAS INTUBATED AS A RESULT. THE PATIENT HAS NOT BEEN FOLLOWED SINCE THE IMPLANT OF THE DEVICE IN 2001. INTERROGATION OF THE DEVICE INDICATED THAT THE DEVICE REACHED END OF LIFE IN NOVEMBER 2009.

    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 84 YR Life Threatening (B)(4)| 2102| (B)(4)| 1280