BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6814415 · Received August 23, 2017

    Report

    Report Number
    3004209178-2017-17991
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    January 19, 2016
    Report Date
    September 13, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761057
    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

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES DISCOVERED ON CONTACT 0 PRIOR TO AN INS REPLACEMENT SURGERY TODAY. IMPEDANCES ON CONTACT 0 WERE IN THE 25000 OHM RANGE. DURING THE POST-OPERATIVE CHECK THEY HAD HIGH IMPEDANCE, BUT THEY WERE LOWER WITH VALUES OF: C0 8570 C1 676 C2 655 C3 692 01 8001 02 8189 03 8320 12 689 13 883 23 695 THE PATIENT WAS NOT PROGRAMMED WITH 0, WITH THE ACTIVE ELECTRODES BEING C+, 2- AND 1-. THE HEALTHCARE PROVIDER (HCP) LOWERED THE AMPLITUDE FROM 5.2 TO 4.7 PRIOR TO THE PROCEDURE WITH THE NEW BATTERY, AS IS STANDARD DURING A BATTERY CHANGE. THE HCP INDICATED THE PATIENT WAS HAVING INCREASED TREMORS. THIS WAS A SUDDEN CHANGE IN THERAPY. THE REP FOLLOWED UP ROUGHLY ON ONE WEEK LATER INDICATING THE PATIENT WAS SCHEDULED TO BE POSSIBLY REPROGRAMMED IN A FEW WEEKS TO INCREASE THE AMPLITUDE AGAIN IF NECESSARY. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) LATER REPORTED THE HIGH IMPEDANCE ON ELECTRODE 0 WAS SEEN BEFORE ON (B)(6) 2016, BUT WAS NOT USED IN PROGRAMMING. THE PATIENT WAS LAST SEEN IN (B)(6)2017, BUT THE PATIENT WAS NOT PROGRAMMED ON C+, 2- AND 1- AT THIS LAST OFFICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594802 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR