BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY IPG

    MDR report key: 6953697 · Received October 16, 2017

    Report

    Report Number
    1627487-2017-06188
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 22, 2017
    Report Date
    November 27, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICES ARE RETURNED TO THE MANUFACTURER, NO ANALYSIS WILL BE PERFORMED AS THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE DBS IPG POCKET. CONSEQUENTLY, THE PATIENT'S IPG WAS REMOVED. CULTURES TAKEN IDENTIFIED A STAPHYLOCOCCUS SPECIES.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED IDENTIFIED THE INFECTION HAD RESOLVED AS THE PATIENT WAS RESCHEDULED FOR RE-IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731324 INFINITY IPG DBS IPG MHY ST. JUDE MEDICAL - NEUROMODULATION 6662 5953106

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other