BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX II

    MDR report key: 2042385 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01491
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE HAD STOPPED WORKING. AS A RESULT, IT WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 74 YR Required Intervention 4017| 4016| MISMATCH| 1280