BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8367398 · Received February 25, 2019

    Report

    Report Number
    3004209178-2019-03909
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 21, 2019
    Report Date
    March 11, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP INDICATING THE CAUSE OF THE HIGH IMPEDANCES WERE NOT DETERMINED. NO TROUBLESHOOTING STEPS WERE TAKEN. THE PATIENT WENT FOR A CATSCAN INSTEAD OF AN MRI. UNKNOWN IF THE ISSUE IS RESOLVED. IT WAS NOT AT THE TIME THEY SAW THE PATIENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT NEEDED A FULL BODY MRI AND THE PATIENT'S IMPEDANCES WERE ELEVATED ON THE TABLET AND NEAR THE THRESHOLDS ON THE 8840. TABLET IMPEDANCES WERE: C/8 = 6617, 8/11 = 7262, 8/10 = 5844, THE 8840 MEASURED AT 3V SHOWED: C/8 = 2426; 8/11=4433; 8/10 =3346, 8/9 = 3505. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159158 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR