BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7527629 · Received May 18, 2018

    Report

    Report Number
    3004209178-2018-11332
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AWARE DATE OF ADDITIONAL INFORMATION HAS BEEN CORRECTED TO (B)(4) 2018 RATHER THAN (B)(4) 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. 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.

    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) STATING THE CAUSE OF THE INS DRAINING FASTER THAN BEFORE/FREQUENT RECHARGING WAS NOT DETERMINE OTHER THAN THE PATIENT'S SETTINGS. IT WAS REPORTED NO ACTION HAD ACTUALLY RESOLVED THE INS DRAIN. THEY HAD THE PATIENT CHARGE TO 100% THEN TRACK THE RATE OF DEPLETION. IT SEEMED THE DEPLETION WAS ABOUT 4 DAYS WHICH WAS ABOUT 1.5 DAYS SHORTER THAN PREDICTED. IT WAS REPORTED NOTHING HAD CHANGED WITH HER PARAMETERS AND SINCE THEY COULD NOT LOWER THE DRAIN ON THE BATTERY (DUE TO DECREASED EFFICACY) IT WAS THE SAME. THE ISSUE WAS NOT RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT HAS NOTICED MORE FREQUENTLY RECHARGING AND THE INS WAS DRAINING QUICKER. THE PARAMETERS USED WERE 3.0 210 150 RAT 940, 5.0 450PW 150 860, 25% AT 4.1DAYS AND 0% AT 5.5DAYS. THE PATIENT WAS CHARGING DAILY BUT IT WAS NOT LASTING A FULL 24 HOURS. THIS WAS DIFFERENT THAN BEFORE. THE THERAPY IMPEDANCE IS 940 AND 860 OHMS. EIGHT COUPLING BAR AVERAGE WAS REPORTED. THE CALLER IS GOING TO HAVE THE PATIENT BRING THEIR INSR (RECHARGER) TO THE APPOINTMENT. IT WAS ALSO NOTED THE HEALTHCARE PROVIDER (HCP) TOLD THEM THAT THE PATIENT CHARGES LESS THAN 1 HOUR BUT STAYS AROUND 50-75% AT THE END OF THE PREVIOUS SESSIONS. NO TROUBLESHOOTING COULD BE PERFORMED AT THIS TIME. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THE CAUSE OF THE INS DRAINING QUICKLY WAS STILL NOT DETERMINED. THE PATIENT WAS INSTRUCTED TO DO A FULL CHARGE AND SEE HOW LONG IT TOOK AND TRACK THE DRAIN OF THE BATTERY TO SEE IF IT WAS IN LINE WITH PREDICATED DRAINING. THE ISSUE HAD NOT BEEN RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369488 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1