BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5530278 · Received March 28, 2016

    Report

    Report Number
    3004209178-2016-05516
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Report Date
    March 28, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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

    A COMPANY REPRESENTATIVE REPORTED THAT THE PATIENT WAS GETTING GOOD THERAPY AND WAS NOT EXPERIENCING ANY ISSUES OR SHOCKING. REP WANTED TO REVIEW IMPEDANCE MEASUREMENTS ON THE DAY OF THIS CALL. THE IMPEDANCE ON THE LEFT SIDE READ: C0 3547 C1 881 C2 925 C3 1020 01 2894 02 3930 03 4308 12 1131 13 1460 23 1208. THE PATIENT HAD 4 GROUPS BUT WAS USING C WHICH WAS PROGRAMMING ON 3- 2- 1+ ON LEFT AND 11- 10- 9+ ON RIGHT. IT WAS INDICATED THAT C0 AND 03 IMPEDANCES WERE SLIGHTLY HIGH BUT SINCE THEY WERE NOT BEING USED IN PROGRAMMING AND PATIENT WAS GETTING GOOD THERAPY, THEY COULD SIMPLY MONITOR IMPEDANCE AND CHECK AGAIN IF PATIENT HAS CHANGE IN THERAPY. REP STATED HE DID NOT OBTAIN IMPEDANCE MEASUREMENTS FOR RIGHT SIDE. A WEEK LATER, REP FURTHER REPORTED THAT THE IMPEDANCES WERE HIGH BUT CONTACT WAS NOT BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185636 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1