BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8410218 · Received March 11, 2019

    Report

    Report Number
    3004209178-2019-04998
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 11, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT THE CALLER STATED FOLLOWING THE PATIENT¿S REPLACEMENT THEY HAD A REVISION IN (B)(6) 2018. THE CALLER COULDN¿T PROVIDE INFORMATION ABOUT WHAT OCCURRED IN THE REVISION. SINCE THE REVISION THE RIGHT SIDE STOPPED WORKING. THE CALLER STATED THAT THERAPY PARAMETERS WERE 2.5V, 80US, 100HZ AND 2.7V, 80US, 100HZ. THE CALLER REPORTED THAT THE CURRENT BATTERY VOLTAGE WAS 2.86V. THE CALLER ASKED ABOUT THE VOLTAGE AS THE INS WAS JUST IMPLANTED IN (B)(6) 2018. TECHNICAL SERVICES REVIEWED INFORMATION ABOUT BATTERY DEPLETION AND LOW IMPEDANCES. THE CALLER RAN THE ELECTRODE IMPEDANCE USING THE TABLET AND PROVIDED THE FOLLOWING VALUES: L STN ALL ¿NORMAL.¿ R ALL READ, 210, 197, 164, 811, 209 OHMS, 911, 209 OHMS, 1011, 208 OHMS, 810, 186 OHMS, 910, 184 OHMS, 89 LOW. THE CALLER INDICATED THAT THE THEY WOULD TRY TO FIND IMPEDANCES FROM PRIOR APPOINTMENTS AND X-RAYS. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203146 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention