BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6955146 · Received October 17, 2017

    Report

    Report Number
    3004209178-2017-21944
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    October 16, 2017
    Report Date
    January 12, 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
    MN, US
    Reporter Occupation
    OTHER

    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. IT WAS NOTED THE CAUSE OF THE ELEVATED IMPEDANCE HAD NOT BEEN DETERMINED. THE PATIENT WAS GETTING EFFECTIVE THERAPY AT THE CONTACTS THAT WERE PROGRAMMED. THE PHYSICIAN WAS TO CONTINUE TO MONITOR AND CHECK IMPEDANCE. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTI MULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THE PAIRS WITH 8 HAD ELEVATED IMPEDANCES: C8 2494 OHMS 89 2965 OHMS 810 3409 OHMS 811 4316 OHMS. THE IMPEDANCE RESULTS WERE FROM AN IMPEDANCE TEST RUN AT 3 V. THE PATIENT INQUIRED ABOUT AN MRI. THE CALLER STATED THAT THE PATIENT WAS PROGRAMMED USING 9 AND 10 AND WAS GETTING GOOD THERAPY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735654 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR