BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7511799 · Received May 14, 2018

    Report

    Report Number
    3004209178-2018-10838
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    May 10, 2018
    Report Date
    May 23, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL, MOVEMENT DISORDERS. IT WAS REPORTED THAT TROUBLESHOOTING WAS NEEDED FOR AN IMPEDANCE ISSUE. THE FOLLOWING WAS REPORTED ABOUT THE PATIENT'S THERAPY AND REP WANTED TO CHECK PATIENT'S IMPEDANCE FOR MRI OF PATIENT'S BACK. C&8, 4108, C&9, 2780, C&10, 1487, C&11, 1811, 8&9, 5548, 8&10, 4467, 8&11, 5091, 9&10, 3056, 9&11, 3876, 10&11, 2193. RIGHT STN C 10+ 4.1 VOLTS 60HZ 150 USEC THE OTHER SIDE WAS FINE PER THE REP. PATIENT SERVICES TOLD THE CALLER THAT AN MRI WAS NOT RECOMMENDED. PATIENT WAS DUE TO HAVE INS REPLACMENT IN 6 MONTHS. DISCUSS CHECKING SYSTEM FOR ISSUES DURING REPLACEMENT. PATIENT'S HAD NO SYMPTOM ISSUES. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    (B)(6) 2018 CRTS (B)(6) (REP): INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULA TOR (INS) FOR PARKINSON'S DUAL, MOVEMENT DISORDERS. IT WAS REPORTED THAT TROUBLESHOOTING WAS NEEDED FOR AN IMPEDANCE ISSUE. THE FOLLOWING WAS REPORTED ABOUT THE PATIENT'S THERAPY AND REP WANTED TO CHECK PATIENT'S IMPEDANCE FOR MRI OF PATIENT'S BACK. C<(>&<)>8 4108 C<(>&<)>9 2780 C<(>&<)>10 1487 C<(>&<)>11 1811 8<(>&<)>9 5548 8<(>&<)>10 4467 8<(>&<)>11 5091 9<(>&<)>10 3056 9<(>&<)>11 3876 10<(>&<)>11 2193. RIGHT STN C 10+ 4.1 VOLTS ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE IMPEDANCES WERE TESTED SEVERAL TIMES WITH THE NEUROLOGIST WITH THE SAME RESULT, AND NO CAUSE OF THE HIGH IMPEDANCES DETERMINED. IT WAS DECIDED THE PATIENT WAS GOING TO WAIT UNTIL THEIR BATTERY WAS CHANGED TO SEE IF THE ISSUE RESOLVED. IT WAS NOTED HEALTHCARE PROVIDER (HCP) WAS AWARE OF THESE ISSUES. NO FURTHER COMPLICATIONS WERE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354073 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR