BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6814416 · Received August 23, 2017

    Report

    Report Number
    3007566237-2017-03458
    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
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    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

    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 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.

    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. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593471 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR