BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6051150 · Received October 24, 2016

    Report

    Report Number
    3004209178-2016-22374
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    July 25, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: 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 HAS A SORE ON THEIR SCALP THAT WAS CLOSE ENOUGH TO THE INCISION AND 6-8 WEEKS PRIOR TO DATE NOTIFIED THEY DECIDED TO OPEN THE INCISION AND MOVE THE LEAD AWAY FROM THE SORE. IT WAS MOVED ON (B)(6) 2016 AND AT THIS POINT IT LOOKS GREAT. THE PATIENT'S INDICATION FOR IMPLANT IS ESSENTIAL TREMOR AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701342 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention