BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5320221 · Received December 22, 2015

    Report

    Report Number
    3004209178-2015-25435
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    December 2, 2015
    Report Date
    December 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WHOSE INDICATION FOR USE IS DYSTONIA HAD EXPERIENCED A NOT NOTICEABLE CHANGE IN THERAPY. IMPEDANCE WERE RUN AT 3V, SETTING FOR RIGHT GLOBUS PALLIDUS (GPI) WERE C+ 9-, 3.7V, 90US AND 130HZ. IMPEDANCE VALUES WERE C/10-2884 OHMS, C/11-2448 OHMS, 8/10-4721 OHMS, 10/11-5215 OHMS AND 8/11-4318 OHMS. C/9 HISTORICAL VALUE WAS 1224 OHMS AND WAS 1327 THE DAY PRIOR. LEFT SIDE IMPEDANCE WAS NORMAL. THE PATIENT HAD HAD ONE TO TWO FALLS PER WEEK BUT HAD NOT HIT THEIR HEAD. NO PATIENT SYMPTOMS WERE REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION ABOUT ONSET, RELATION TO DEVICE/THERAPY, CAUSE AND ACTIONS TAKEN. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845965 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR