BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 13052542 · Received December 21, 2021

    Report

    Report Number
    3004209178-2021-18864
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 21, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864191
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE IS AN ESTIMATED DATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS HAD ANXIETY AND DEPRESSION THE LAST COUPLE MONTHS. THEY HAVE THE DEVICE FOR TREMOR AND SAID THEY LIKED THEIR SETTINGS BUT WONDERED IF THE DEVICE COULD BE ADJUSTED TO HELP WITH THE ANXIETY/DEPRESSION. THEY WERE AFRAID OF GETTING THE DEVICE ADJUSTED BECAUSE THEY'VE HAD THEIR DBS TURNED OFF AND BACK ON AND THEY EXPERIENCED A "ZING" SENSATION THAT THEY DESCRIBED AS THE DEVICE ELECTROCUTING THEM. THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE WERE ASKED BUT UNKNOWN. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951182 ACTIVA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169864191

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female