BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 10701700 · Received October 19, 2020

    Report

    Report Number
    3004209178-2020-18239
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Report Date
    October 19, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000175719
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SHOCKING AND ZAPPING ON THE RIGHT SIDE WHERE THE INS WAS IMPLANTED. THEY ALSO KEPT HAVING DOUBLE VISION AND SEEING FLASHING LIGHTS. STIM IS KEPT ON AT ALL TIMES. IMPEDANCES WERE TAKEN AND LISTED AS BELOW:  LEFT SIDE: C0: 1555 OHMS C1: 814 OHMS C2: 502 OHMS C3: 2729 OHMS 01: 1462 OHMS 02: 1623 OHMS 03: 3584 OHMS 12: 808 OHMS 13: 2942 OHMS 23: 2321 OHMS  RIGHT SIDE C4: 875 OHMS C5: 917 OHMS C6: 1023 OHMS C7: 1099 OHMS 4/5: 1115 OHMS 4/6: 1498 OHMS 4/7: 1677 OHMS 5/6: 1213 OHMS 5/7: 1597 OHMS 6/7: 1354 OHMS THE SYMPTOMS WERE NOT EXPERIENCED DURING THE IMPEDANCE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167098 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00763000175719

    Patients

    Seq Age Sex Outcome Treatment
    1