BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6872934 · Received September 18, 2017

    Report

    Report Number
    9614453-2017-03313
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Date of Event
    May 15, 2017
    Report Date
    November 21, 2017
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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.

    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 HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT DIAGNOSTICS WERE TAKEN ON (B)(6) 2017 WHICH SHOWED THAT THERE WERE HIGH IMPEDANCES SEEN ON SLOT 0 AND 1 OF THE LEFT LEAD, AND ON SLOT 8-9 AND 11 OF THE RIGHT LEAD. HOWEVER, IT WAS NOTED THAT THESE SLOTS AREN'T USED IN THERAPY. THE ETIOLOGY OF THE EVENT WAS NOTED TO BE RELATED TO THE DEVICE OR THERAPY, AND NOT RELATED TO THE IMPLANT PROCEDURE. THERE WERE NO ACTIONS/INTERVENTIONS TAKEN, WITH THE OUTCOME LISTED AS UNRESOLVED WITH NO FURTHER ACTION PLANNED. NO PATIENT SYMPTOMS WERE ALLEGED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP UPDATED THE SIGNS SYMPTOMS TO REITERATE HIGH IMPEDANCE ON ELECTRODE 0 AND 1 OF THE LEFT LEAD AND ON ELECTRODE 8-9 AND 11 OF THE RIGHT LEAD, WITH THESE ELECTRODES NOT USED IN THERAPY. IMPEDANCE VALUES WERE ALSO GIVEN AS FOLLOWS: ELECTRODE 0 = 2713 OHMS, ELECTRODE 1 = 2158 OHMS, ELECTRODE 8 = 3346 OHMS, ELECTRODE 9 = 3280 OHMS, ELECTRODE 11 = 3355 OHMS. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653292 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC EUROPE SARL 37601

    Patients

    Seq Age Sex Outcome Treatment
    1