BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6010687 · Received October 7, 2016

    Report

    Report Number
    3004209178-2016-21285
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT ON (B)(6) 2016, BLOODWORK WAS PERFORMED ON THE PATIENT AND RESULTED IN AN UTI. THE CONSUMER ALSO STATED THE RESULTS WERE "UNTRUTH"; IT IS UNKNOWN WHAT THIS STATEMENT MEANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663279 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other