BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 9272182 · Received November 4, 2019

    Report

    Report Number
    3004209178-2019-20967
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    April 3, 2019
    Report Date
    December 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000175719
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    IT WAS REPORTED THAT THEY WERE FILLING OUT THE MRI FORM AND STATED THAT THE PATIENT HAS OUT OF RANGE IMPEDANCES (C2 2344, 02 4326). THE LABELING WAS REVIEWED WITH THEM. IT WAS ALSO REVIEWED THAT IMPEDANCES SHOULD NOT BE LOOKED AT INDEPENDENTLY AND TO TAKE OTHER THINGS INTO CONSIDERATION, SUCH AS HISTORICAL IMPLANTS, FALLS OR TRAUMA, OR CHANGE IN THERAPY TO GET A FEEL FOR SYSTEM INTEGRITY. THEY INDICATED THAT DUE TO THE FALLS, THEY DO NOT WANT TO SIGN OFF ON THE MRI. IT WAS REVIEWED TO NOT PERFORM THE MRI IF THEY ARE CONCERNED WITH THE SYSTEM INTEGRITY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE FALL WAS DETERMINED TO BE "MECHANICAL." THE CAUSE OF THE OUT OF RANGE IMPEDANCES WERE NOT DETERMINED. IMPEDANCES WERE CHECKED AND NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE OUT OF RANGE IMPEDANCES. THE OUT OF RANGE IMPEDANCES WERE NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070206 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00763000175719

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR