BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6439889 · Received March 28, 2017

    Report

    Report Number
    3007566237-2017-01164
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    January 27, 2017
    Report Date
    March 28, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    ALLERT N, BARBE MT, TIMMERMAN L, COENEN VA. RAPID BATTERY DEPLETION AND LOSS OF THERAPY DUE TO A SHORT CIRCUIT IN BIPOLAR DBS FOR ESSENTIAL TREMOR. ACTA NEUROCHIR DOI: 10.1007/S00701-017-3090-7 ABSTRACT: TECHNICAL DYSFUNCTIONS HAVE BEEN REPORTED REDUCING EFFICACY OF DEEP BRAIN STIMULATION (DBS). HERE, WE REPORT ON AN ESSENTIAL TREMOR PATIENT IN WHOM A SHORT CIRCUIT IN BIPOLAR DBS RESULTED NOT ONLY IN UNILATERAL LOSS OF THERAPY BUT ALSO IN HIGH CURRENT FLOW AND THEREBY RAPID DECLINE OF THE IMPULSE-GENERATOR BATTERY VOLTAGE FROM 2.83V A WEEK BEFORE THE EVENT TO 2.54V, INDICATING THE NEED FOR AN IMPULSE-GENERATOR REPLACEMENT. IMMEDIATE REPROGRAMMING RESTORED THERAPEUTIC EFFICACY. MOREOVER, THE REDUCTION IN CURRENT FLOW ALLOWED THE BATTERY VOLTAGE TO RECOVER WITHOUT IMMEDIATE SURGICAL INTERVENTION TO 2.81V A WEEK LATER. REPORTED EVENTS: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL VENTRAL INTERMEDIATE NUCLEUS (VIM) OF THE THALAMUS DEEP BRAIN STIMULATION (DBS) FOR ESSENTIAL TREMOR. THE PATIENT LATER UNDERWENT TWO BATTERY REPLACEMENTS MORE THAN TWO YEARS LATER; THERE WAS A PREVIOUSLY REPORTED SHORT CIRCUIT. THE SHORT CIRCUIT WAS STABLE FOR ONE YEAR AFTER THE MOST RECENT REPLACEMENT (BIPOLAR IMPEDANCE AT 100HZ, 80 ¿S, AND 0.7V BETWEEN 56 AND 58 O) BEFORE AND AFTER 1.5 AND 2 YEARS AT UNEVENTFUL CONTROL VISITS WITHOUT CHANGE IN TREMOR CONTROL. THE PREVIOUS REPROGRAMMING HAD RESULTED IN STABLE SYMPTOM CONTROL AND THERAPEUTIC IMPEDANCE/CURRENT FLOW, ALTHOUGH TWO YEARS AFTER THE INS REPLACEMENT, THE BIPOLAR IMPEDANCE HAD INCREASED FROM 58 TO 1385O AGAIN. THE IMPEDANCE AND CURRENT AT THE EFFECTIVE STIMULATION PARAMETERS FOR THE LEFT VIM WAS NOT INFLUENCED BY THIS IMPEDANCE CHANGE: 1130 O AND 3703MA ONE YEAR AFTER THE LAST INS REPLACEMENT AND 1056 O AND 3864MA ONE YEAR LATER. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3389; ACTIVA RC MODEL 37612. SEE MANUFACTURING REPORT # 3007566237-2017-01161 FOR THE PREVIOUS REPORT OF SHORT CIRCUIT AND BATTERY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223461 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR