BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7956507 · Received October 11, 2018

    Report

    Report Number
    3004209178-2018-22798
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    October 10, 2018
    Report Date
    October 15, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) STATING THAT THE CAUSE OF HIGH IMPEDANCES WAS NOT KNOWN. THE REP LEARNED OF HIGH IMPEDANCES FROM THE DOCTOR AND TOGETHER THEY SAW THE PATIENT IN THE CLINIC.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT PATIENT CAME IN AND PRESENTED WITH FINE WITH MILD TO NO SYMPTOMS. PATIENT WAS THERE BECAUSE THEY HAD HURTING ANKLE AND KNEE. THE REP RAN IMPEDANCE CHECK AND EVERYTHING WITH 3 WAS >40K AND EVERYTHING WITH 2 WAS >30K. PATIENT WAS PROGRAMMED ON 2 & 3. PROGRAMMING WAS CHANGED TO CONTACT 1 AND PATIENT BECAME DYSTONIC TRUNCAL AND NECK. THE REP INCREASED VOLTAGE AND GOT SIDE EFFECT SO PATIENT WAS CHANGED AGAIN TO MONOPOLAR SETTINGS WITH C & 1 AND INCREASED TO JUST BELOW SIDE EFFECT. THE PATIENT HAD DECENT BENEFIT AND THEY WILL WATCH HER. THE REP NOTED THAT THE IMPEDANCES WERE CHECKED WITH THE CLINICIAN PROGRAMMER AND THE TABLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799241 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR