BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7651612 · Received June 29, 2018

    Report

    Report Number
    3004209178-2018-14697
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 26, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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.

    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) VIA A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SUDDEN URGENCY OF URINATION AND FEELS THAT IT IS DUE TO THE STIMULATION OF THEIR INS. PATIENT STATED THAT WHEN THEY TURNED OFF HIS INS THAT THE URGENCY RESOLVED. DIAGNOSTICS/TROUBLESHOOTING INCLUDED INTERROGATING THE INS SYSTEM AND ALL IMPEDANCES ARE WITHIN NORMAL RANGE. INTERVENTIONS/ACTIONS INCLUDED CREATING A NEW GROUP "C" SETTING OF THE INS. IT IS UNKNOWN IF THE ISSUE IS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT. IMPEDANCE RESULTS: HEMISPHERE LEFT AMPLITUDE: 3.00 C , 0 794 0, 2 1949 C, 1 892 0, 3 2497 C, 2 1052 1, 2 1850 C, 3 1528 1, 3 2406 0, 1 1578 2, 3 2447 HEMISPHERE RIGHT AMPLITUDE: 3.00 C, 8 1091 8, 10 2082 C, 9 1071 8, 11 2278 C, 10 1238 9, 10 1722 C, 11 1225 9, 11 2144 8, 9 1685 10, 11 1739.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE INDICATING THAT ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE SUDDEN URGENCY OF URINATION WAS THAT THEY CREATED A NEW GROUP SETTING. THE CAUSE OF THE ISSUE IS UNKNOWN AND IT IS UNKNOWN IF IT IS RESOLVED. THIS INFORMATION WAS CONFIRMED BY THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493153 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR