BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6139413 · Received December 1, 2016

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    Report

    Report Number
    3004209178-2016-24996
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    October 31, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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

    THE PATIENT REPORTED A SUDDEN RETURN OF SYMPTOMS IN THEIR RIGHT HAND WITH STIMULATION VERIFIED TO BE ON AS OF ABOUT 1.5 WEEKS PRIOR TO DATE NOTIFIED. IT WAS STATED THAT THEY WERE IMPLANTED ON THE LEFT SIDE AND AFTER IMPLANT THEIR RIGHT HAND WAS GOOD. THEY THEN HAD AN ADJUSTMENT WITH THEIR LOCAL DOCTOR WHO MADE AN ADJUSTMENT AND THEIR RIGHT HAND IS NOW SHAKING WORSE THAN BEFORE IMPLANT. ON (B)(6) THE PATIENT REPORTED THAT THEIR TREMORS ARE REALLY BAD AND ARE WONDERING IF THE IMPLANT IS TURNED OFF. THERAPY WAS CHECKED WITH THE PATIENT PROGRAMMER (PP) AND IT WAS CONFIRMED THAT THEY ARE GETTING A LOW BATTERY INFORMATIONAL SCREEN, INDICATING THAT THE IMPLANT NEEDS TO BE RECHARGED. THE PATIENT ATTEMPTED TO CHARGE AND WAS ABLE TO GET ALL 8 COUPLING BARS. FOLLOW UP WITH THE HEALTHCARE PROVIDER (HCP) IS TO BE CONDUCTED. THE PATIENT'S INDICATION FOR IMPLANT IS ESSENTIAL TREMOR AND MOVEMENT DISORDERS. SEE RELATED PE 3004209178-2016-24994.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789350 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR