BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6439791 · Received March 28, 2017

    Report

    Report Number
    3007566237-2017-01161
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 14, 2014
    Report Date
    May 2, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE EXTENSION.

    Additional Manufacturer Narrative · 1

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

    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. IT WAS NOTED THAT THE PATIENT HAD BEEN IMPLANTED WITH A HEART PACEMAKER FOR SYMPTOMATIC BRADYCARDIA AT THE AGE OF 70; TO AVOID INTERACTION WITH THE SENSING OF THE HEART PACEMAKER, BIPOLAR STIMULATION WAS USED FOR DBS. THE PATIENT EXPERIENCED SIGNIFICANT TREMOR REDUCTION WITH THE FOLLOWING PARAMETERS ON THE LEFT AND RIGHT, RESPECTIVELY: 130HZ, CONTACT 0 NEGATIVE/CONTACT 1 POSITIVE, 90¿S, AND 5.0-5.5V; 130HZ, CONTACT 8 POSITIVE/CONTACT 9 NEGATIVE, 90¿S, AND 5.0-5.5V. TWO YEARS LATER, THE PATIENT UNDERWENT AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT. IMPEDANCE MEASUREMENTS TAKEN NINE DAYS AFTER THE REPLACEMENT AND AT REGULAR CONTROL VISITS DURING THE NEXT NINE MONTHS WERE UNEVENTFUL. THE RESIDUAL TREMOR INTENSITY WORSENED SLOWLY OVER TIME. REPROGRAMMING OF STIMULATION PARAMETERS RESULTED IN TRANSIENT TREMOR IMPROVEMENTS BEFORE HABITUATION OVER DAYS TO WEEKS. THEREFORE, FIVE MONTHS AFTER THE INS REPLACEMENT, A SECOND PREDEFINED STIMULATION GROUP WAS PROGRAMMED: (LEFT VIM) 180HZ, CONTACT 0 NEGATIVE/CONTACT 1 POSITIVE, 210¿S, AND 4.0V; (RIGHT VIM) 180HZ, CONTACT 8 POSITIVE/CONTACT 9 NEGATIVE,210¿S AND 4.0V. FOR A COUPLE OF MONTHS, THE PATIENT REGULARLY CHANGED BETWEEN THESE STIMULATION GROUPS BEFORE KEEPING THE LATTER GROUP AS THE SLIGHTLY MORE EFFICIENT SETTING. THE INS BATTERY VOLTAGE DECREASED SLOWLY AFTER THE INS REPLACEMENT BEFORE THE PATIENT SUDDENLY DEVELOPED A SEVERE RIGHT-SIDED TREMOR AS IF DBS WAS SWITCHED OFF. THE PATIENT PROGRAMMER REPORTED STIMULATION TO BE ¿ON¿ BUT INDICATED THAT BATTERY VOLTAGE HAD DROPPED TO 2.54V AND THAT AN ELECTIVE REPLACEMENT WAS INDICATED (ERI). ONE WEEK EARLIER, THE BATTERY VOLTAGE HAD STILL BEEN 2.83V. CHANGING TO THE OTHER PREDEFINED STIMULATION GROUP DID NOT RESTORE TREMOR SUPPRESSION ON THE RIGHT. AT AN IMMEDIATE EMERGENCY OUTPATIENT VISIT, TELEMETRIC EVALUATION BY THE CLINICIAN¿S PROGRAMMER REVEALED A SHORT CIRCUIT OF THE ACTIVE CONTACTS 0 AND 1. THE BIPOLAR IMPEDANCE OF THESE CONTACTS AT 100HZ, 80¿S, AND 0.7V WAS 39O COMPARED TO 1604O SEVEN WEEKS BEFORE. CORRESPONDINGLY, THE IMPEDANCE AT THE SELECTED EFFECTIVE STIMULATION PARAMETERS ALSO REVEALED THE BIPOLAR IMPEDANCE OF CONTACT 0 AND 1 AS LOW (63 O) AND THE CURRENT FLOW AS ¿HIGH.¿ THE SHORT CIRCUIT HAD RESULTED IN HIGH CURRENT FLOW AND CORRESPONDING DECLINE IN BATTERY VOLTAGE TO 2.54V. HOWEVER, THE IMMEDIATE DETECTION AND REPROGRAMMING PREVENTED COMPLETE BATTERY DEPLETION. REPROGRAMMING STIMULATION PARAMETERS OF THE LEFT VIM AT THE FOLLOWING SETTING ALLOWED RESTORING THE SAME LEVEL OF TREMOR CONTROL AS BEFORE: 180HZ, CONTACT 0 AND 1 NEGATIVE/CONTACT 2 POSITIVE, 210¿S, AND 4.0V. IN CHOOSING THE SHORT CIRCUITED CONTACTS TOGETHER AS A CATHODE, STIMULATION OF A CONSTANT VOLUME OF TISSUE AT THE ELECTRODE TIP WAS ABLE TO BE RE-ESTABLISHED. THE REPROGRAMMING HAD REDUCED THE CURRENT FLOW AND A SIGNIFICANT BATTERY RECOVERY EFFECT WAS OBSERVED. THE INS BATTERY VOLTAGE INCREASED WITHIN 30 MINUTES TO 2.69V AND AT ANOTHER CONTROL VISIT ONE WEEK LATER TO 2.81V. THIS REPROGRAMMING AND BATTERY RECOVERY MADE FURTHER EVALUATION POSSIBLE AND PREVENTED AN EMERGENCY REPLACEMENT. TREMOR CONTROL WAS AS EFFICIENT AS BEFORE AND THE SHORT CIRCUIT REMAINED STABLE DURING THE FOLLOWING CONTROL VISITS. AN ELECTIVE INS REPLACEMENT WAS PERFORMED AFTER ANOTHER THREE MONTHS. BECAUSE TREMOR WAS EFFICIENTLY CONTROLLED AS BEFORE THE SHORT CIRCUIT, THE INS WAS REPLACED BY A RECHARGEABLE INS WITHOUT FURTHER EXPLORATION OF THE SHORT CIRCUIT LOCATION (ELECTRODE OR EXTENSION WIRE); HOWEVER, THE SHORT CIRCUITED PERSISTED FOLLOWING INS REPLACEMENT. TREMOR CONTROL WAS STABLE THEREAFTER WITH SLOW DETERIORATION DURING THE FOLLOWING TWO YEARS DUE TO DISEASE PROGRESSION. IT WAS CONCLUDED THAT THE SHORT CIRCUIT OF ACTIVE CONTACTS IN BIPOLAR DBS RESULTED NOT ONLY IN UNILATERAL THERAPEUTIC LOSS BUT ALSO RAPID BATTERY DEPLETION. EMERGENCY REPROGRAMMING WAS WARRANTED NOT ONLY TO RESTORE THERAPEUTIC EFFECT, BUT ALSO TO SAVE BATTERY VOLTAGE AND GAIN TIME TO CONSIDER THE NEED FOR SURGICAL REVISION OR INS REPLACEMENT. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: ACTIVA PC MODEL 37601; LEAD MODEL 3389.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR REPORTED THAT THE EVENT FIRST OCCURRED ON (B)(6) 2014, WHEN THE PATIENT NOTICED A STRONG TREMOR AND PRESENTED TO THE OUTPATIENT CLINIC. THE SHORT CIRCUIT OCCURRED SPONTANEOUSLY WITHOUT PREVIOUS SURGICAL REVISION, FALL, OR OTHER EVENT. THE SHORT CIRCUIT WAS BETWEEN PREVIOUSLY ACTIVE CONTACTS 0 AND 1 OF THE LEFT-HEMISPHERIC ELECTRODE; BIPOLAR IMPEDANCE BETWEEN THESE CONTACTS WAS 39 OHMS. REPROGRAMMING ALLOWED RESTORATION OF THE SAME TREMOR SUPPRESSION/THERAPEUTIC EFFICACY AS PRIOR TO THE SHORT CIRCUIT; THEREFORE, NO SURGICAL REVISION WAS RECOMMENDED AND NO X-RAYS OR CT SCANS WERE PERFORMED TO HELP LOCALIZE THE LOCATION OF THE SHORT CIRCUIT. THE MOST LIKELY LOCATION OF THE SHORT CIRCUIT WAS NOTED TO BE THE EXTENSION AS OPPOSED TO THE ELECTRODE. THE ELECTRODE AND EXTENSION WITH THE SHORT CIRCUIT REMAINED IMPLANTED AND IN USE IN THE PATIENT. THERE WAS NO INFORMATION AVAILABLE REGARDING SERIAL OR LOT NUMBERS OF THE INVOLVED DEVICES OR ADDITIONAL PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222278 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR