BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 12900314 · Received November 30, 2021

    Report

    Report Number
    3004209178-2021-17785
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 24, 2021
    Report Date
    November 30, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000310332
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A COUPLE WEEKS AGO THE PATIENT WENT TO THEIR HEALTHCARE PROVIDER AND THEY HAD WANTED PATIENT TO CHANGE FROM GROUP B TO GROUP A BUT WEREN'T ABLE TO DO SO. PATIENT WAS CALLING FOR ASSISTANCE CHANGING FROM GROUP B TO A. PATIENT CONNECTED WITH THE IMPLANT AND THE THERAPY WAS OFF, PATIENT SAID THEY DIDN'T WANT THERAPY OFF AND THEY DIDN'T KNOW IT WAS OFF AND THAT TODAY WAS THE FIRST TIME THEY NOTICED THAT THERAPY WAS OFF. THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE WERE ASKED BUT UNKNOWN. THEY WALKED PATIENT THROUGH TURNING THERAPY BACK ON AND CHANGING FROM GROUP B TO A SUCCESSFULLY. PSS REVIEWED FOR PATIENT TO FOLLOW UP WITH HCP REGARDING ANY FUTURE CHANGES TO THERAPY. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788045 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00763000310332

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male