BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7789074 · Received August 16, 2018

    Report

    Report Number
    3004209178-2018-18396
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    August 13, 2018
    Report Date
    August 29, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 HEALTH CARE PROFESSIONAL (HCP) VIA THE REP STATING THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED. NO ACTIONS/INTERVENTIONS WERE TAKEN, AND THE HIGH IMPEDANCES HAD NOT BEEN RESOLVED AT THE TIME OF THE REPORT.

    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 PARKINSON'S DUAL, MOVEMENT DISORDERS. IT WAS REPORTED THAT PRIOR TO THE SURGERY THE LEFT LEAD IMPEDANCES WERE FOUND TO BE ELEVATED. C0=12563, C1=11460, C2=11673, C3=12872, 01=5855, 02=8667, 03=11544, 12=5122, 13=8667, 23=5226. HERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631535 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR