BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 10733373 · Received October 26, 2020

    Report

    Report Number
    3004209178-2020-18638
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 23, 2020
    Report Date
    October 26, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000100353
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT REPORTED THAT THE DEVICE FLIP FLOPS IN THEIR CHEST, ESPECIALLY WHILE SLEEPING ON THEIR SIDE. IT IS UNKNOWN IF THERE WERE ANY FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO ACTIONS/INTERVENTIONS WERE TAKEN YET TO RESOLVE THE ISSUE AND THE ISSUE HAS NOT BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202681 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00763000100353

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR