BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6050657 · Received October 24, 2016

    Report

    Report Number
    3004209178-2016-22354
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA0405A, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD PRODUCT ID: 3387S-40, LOT# V961943, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. 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

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT'S LAST IMPEDANCE WAS CHECKED IN (B)(6) 2015 WHERE C/0 WAS 2512 OHMS, AND AT THE TIME THE PATIENT WAS COMPLAINING ABOUT SHOCKING IN THEIR SCALP. THEY CHOSE NOT TO USE 0 WHEN PROGRAMMING AS A RESULT. THE PATIENT'S INDICATION FOR IMPLANT IS ESSENTIAL TREMOR AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701088 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR