BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8176664 · Received December 18, 2018

    Report

    Report Number
    3004209178-2018-27949
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 14, 2018
    Report Date
    January 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT IMPEDANCES WERE ELEVATED BEYOND MAGNETIC RESONANCE IMAGING (MRI) LIMITS. IT WAS STATED THE REP WAS DOING A PRE-MRI CHECK DUE TO A BROKEN HIP. IT WAS DISCUSSED THAT THE MONOPOLAR PAIRS WERE ABOVE MRI LIMITS, AND THE PATIENT SHOULD NOT HAVE THE MRI. THE MONOPOLAR PAIRS WERE REPORTED AS HIGH AS 6500 OHMS. THE RIGHT SIDE IMPEDANCE MEASUREMENTS WERE AS FOLLOWS: C0 6456; C1 4701; C2 2233; C3 810; 01 2993; 02 4701; 03 5920; 1, 2 2352; 1, 3 4060; 2, 3 1540. THE LEFT SIDE IMPEDANCE MEASUREMENTS WERE AS FOLLOWS: C0 4134; C1 865; C2 774; C3 800; 01 3168; 02 3803; 03 3995; 1, 2 879; 1, 3 1128; 2, 3 840. NO SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP INDICATING THAT NO TROUBLESHOOTING WAS DONE, JUST CONFIRMED THE HIGH IMPEDANCE WITH THE 8840. NO ACTIONS/INTERVENTIONS WERE TAKEN, THEY WERE TO FOLLOW UP WITH A DOCTOR AT A LATER DATE. THE CAUSE OF THE ISSUE WAS UNDETERMINED. THE ISSUE REMAINS UNRESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013889 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR