BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5791209 · Received July 13, 2016

    Report

    Report Number
    3004209178-2016-14134
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    June 8, 2016
    Report Date
    July 13, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V761180, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V761180, IMPLANTED: (B)(6) 2011, 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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS AT THE HOSPITAL BECAUSE SHE EXPERIENCED A SUDDEN ONSET OF SHOCKING AND WAS ALSO SUDDENLY SHAKING BADLY. IT WAS CONFIRMED THAT NO FALLS OR TRAUMA WERE RELATED TO THE ISSUE. THE SHOCKING WAS REPORTED TO HAVE OCCURRED IN THE PATIENTS RIGHT SHOULDER WHERE THE WIRES GO FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) UP TO BEHIND THE PATIENT'S EAR. IT WAS STATED THAT PATIENT'S FRIEND/FAMILY MEMBER THINKS ONE OF THE WIRES WAS PULLED OUT OF THE INS OR THE COATING MAY BE OFF OF THE WIRE, BUT DOES NOT KNOW AND IS NOT SURE. THE ISSUES BEGAN OCCURRING 1 TO 1.5 WEEKS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444627 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization