BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6214335 · Received December 29, 2016

    Report

    Report Number
    3007566237-2016-04593
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    March 1, 2010
    Report Date
    December 29, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 7428, LOT# UNKNOWN, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7428, LOT# UNKNOWN, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    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.

    Description of Event or Problem · 1

    CUNNINGHAM, MG., YADOLLAHIKHALES, G., VITALIANO, G., VAN HORNE, C. ADMINISTRATION OF ELECTROCONVULSIVE THERAPY FOR DEPRESSION ASSOCIATED WITH DEEP BRAIN STIMULATION IN A PATIENT WITH POST-TRAUMATIC PARKINSON'S DISEASE: A CASE STUDY. BMC PSYCHIATRY. 2016;16(1):399. DOI: 10.1186/S12888-016-1108-Y SUMMARY: DEEP BRAIN STIMULATION (DBS) HAS BEEN SHOWN TO BE EFFECTIVE FOR PARKINSONIAN SYMPTOMS POORLY RESPONSIVE TO MEDICATIONS. DBS IS TYPICALLY WELL-TOLERATED, AS ARE THE MAINTENANCE BATTERY CHANGES. HERE WE DESCRIBE AN ADVERSE EVENT DURING A BATTERY REPLACEMENT PROCEDURE THAT CAUSED RAPID ONSET OF SEVERE DEPRESSION. CASE PRESENTATION: THE PATIENT IS A (B)(6)-YEAR-OLD WOMAN WHO WAS IN A SERIOUS MOTOR VEHICLE ACCIDENT AND SUSTAINED A CONCUSSION WITH LOSS OF CONSCIOUSNESS. WITHIN WEEKS OF THE ACCIDENT, SHE BEGAN DEVELOPING PARKINSONIAN SYMPTOMS THAT PROGRESSIVELY WORSENED OVER THE SUBSEQUENT 10 YEARS. RESPONDING POORLY TO MEDICATIONS, SHE RECEIVED DBS, WHICH CONTROLLED HER MOVEMENT SYMPTOMS. FIVE YEARS AFTER INITIATING DBS, DURING A ROUTINE BATTERY CHANGE, AN APPARENT ELECTRICAL EVENT OCCURRED THAT TRIGGERED THE RAPID ONSET OF SEVERE DEPRESSION. ANTI-SEIZURE AND ANTIDEPRESSANT MEDICATIONS WERE INEFFECTIVE, AND THE PATIENT WAS OFFERED A COURSE OF ELECTROCONVULSIVE THERAPY (ECT), WHICH RESULTED IN COMPLETE REVERSAL OF HER DEPRESSIVE EPISODE. CONCLUSION: PARKINSON¿S SYNDROME CAN BE SEEN AFTER A SINGLE CLOSED HEAD INJURY EVENT. POST-TRAUMATIC PARKINSONISM IS RESPONSIVE TO DBS; HOWEVER, DBS HAS BEEN ASSOCIATED WITH AN INFREQUENT OCCURRENCE OF DRAMATIC DISRUPTION IN MOOD. ECT IS A THERAPEUTIC OPTION FOR PATIENTS WHO DEVELOP INTRACTABLE DEPRESSIVE ILLNESS ASSOCIATED WITH DBS. REPORTED EVENTS: A (B)(6)-YEAR-OLD WOMAN WITH BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) FOR PARKINSON'S DISEASE (PD), IN (B)(6) 2010, HER KINETRA PULSE GENERATOR WAS REPLACED WITH A PC UNIT TO ALLOW FOR MORE PROGRAMMING OPTIONS. WHILE BATTERY REPLACEMENTS ARE TYPICALLY PERFORMED WITH LOCAL ANESTHESIA AND CONSCIOUS SEDATION, THE PATIENT REQUESTED THAT MINIMAL SEDATING MEDICATION BE USED. DURING THE BATTERY REPLACEMENT PROCEDURE, THE PATIENT REPORTED A RAPID ONSET OF UNCOMFORTABLE TINGLING SENSATIONS AND ANXIETY UPON PLACEMENT OF THE BATTERY WITHIN THE SURGICAL POCKET. THE PULSE GENERATOR WAS IMMEDIATELY RETRIEVED, TURNED OFF, AND RE-IMPLANTED ONCE THE PATIENT¿S DISCOMFORT RESOLVED. THE THERAPY WAS REINITIATED IN THE OPERATING ROOM WITHOUT INCIDENT. GIVEN THE CONCERN OVER THE EVENT, SHE WAS OBSERVED OVERNIGHT AS AN INPATIENT. THE FOLLOWING DAY, SHE REPORTED EXPERIENCING NUMEROUS BRIEF ¿SURGES¿ FOLLOWED BY PERIODS OF ANXIETY AND PANIC. NO LOSS OF CONSCIOUSNESS OR CHANGE IN MENTAL STATUS WAS ASSOCIATED WITH THESE EVENTS, AND NO NEUROLOGIC SIGNS WERE NOTED. SHE WAS THEN DISCHARGED HOME WITH HER HUSBAND. AFTER RECOVERY FROM SURGERY, THE PATIENT WAS LEFT WITH ONGOING EPISODES OF ANXIETY AND WITHIN 24 H SHE DEVELOPED SEVERE DEPRESSIVE SYMPTOMS INCLUDING SADNESS, AGITATION, HOPELESSNESS, AN IMPENDING SENSE OF DOOM, AND MORBID SUICIDAL THOUGHTS. WHILE ANXIETY AND DEPRESSED MOOD PREDOMINATED, THE PATIENT REPORTED EXPERIENCING BRIEF EPISODES OF ¿GIDDINESS¿ EVERY 1-3 DAYS. MULTIPLE PROGRAMMING SESSIONS FAILED TO IMPACT HER CONDITION AND THERE WAS CONCERN THAT THE PULSE GENERATOR WAS MALFUNCTIONING. HOWEVER, A REPEAT SCAN REVEALED THAT HER INTRACRANIAL LEADS HAD NOT SHIFTED, AND THEY WERE INDEED APPROPRIATELY PLACED. LEAD INTEGRITY WAS EVALUATED THROUGH X-RAY IMAGING AND ELECTRICAL IMPEDANCE TESTING OF ALL POSSIBLE COMBINATIONS, AND THERE WAS NO EVIDENCE OF ABNORMALITIES. AFTER ELIMINATING ALL OTHER POSSIBLE EXPLANATIONS, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND HER PC PULSE GENERATOR WAS REPLACED BY A NEW KINETRA. HER DEPRESSION AND ANXIETY PERSISTED, HOWEVER, AND SHE REPORTED HAVING INTRUSIVE THOUGHTS, INSOMNIA, ANOREXIA, AND CONSTANT FEELINGS OF DREAD. FIVE DAYS LATER, OVERWHELMED WITH A SENSE OF HOPELESSNESS, THE PATIENT ATTEMPTED SUICIDE BY OVERDOSING ON DIAZEPAM AND ZOLPIDEM. AFTER STABILIZATION AS AN INPATIENT, SHE BEGAN RECEIVING CARE FROM A NEUROPSYCHIATRIST TO ADDRESS HER PSYCHIATRIC SYMPTOMS IN THE CONTEXT OF HER NEUROLOGICAL DISEASE. THE PATIENT WAS EXQUISITELY SENSITIVE TO MEDICATIONS AND ONLY VERY LOW DOSES WERE TOLERATED. SHE WAS GIVEN UNSUCCESSFUL TRIALS OF BENZODIAZEPINES, ANTIDEPRESSANTS, MOOD STABILIZERS, AND ANTIPSYCHOTICS. AFTER A FAILED TRIAL OF VALPROATE, THE PATIENT SHOWED SOME IMPROVEMENT WITH LAMOTRIGINE. ESCITALOPRAM WAS THEN ADDED WITH EQUIVOCAL SUCCESS. THE PATIENT SHOWED ONLY MODEST IMPROVEMENT AFTER 1 YEAR OF MEDICATION TRIALS, PSYCHOTHERAPY, AND COGNITIVE BEHAVIORAL THERAPY (CBT), AS WELL AS ALTERNATIVE MEDICINE INTERVENTIONS, INCLUDING ACUPUNCTURE AND THERAPEUTICALLY-INDUCED DISSOCIATION. WITH HER THEN EXISTING BATTERY LOSING ITS CHARGE, AND WITH PERSISTING SUSPICION OF BATTERY MALFUNCTION, IN 2011, HER KINETRA BATTERY WAS REPLACED AGAIN WITH NO APPARENT EFFECT ON MOOD SYMPTOMS. ALTHOUGH HER PARKINSONIAN SYMPTOMS WERE ADEQUATELY TREATED, HER SEVERE MOOD DISORDER WAS UNRELENTING AFTER ONGOING MEDICATION REVISIONS WITH CONTINUED PSYCHOTHERAPY AND CBT. HER STIMULATION PARAMETERS WERE ADJUSTED NUMEROUS TIMES IN AN ATTEMPT TO ATTENUATE THE MOOD SYMPTOMS WHILE MAINTAINING CONTROL OVER HER MOVEMENT DISORDER. NEITHER THESE ADJUSTMENTS NOR TURNING OFF THE STIMULATION ENTIRELY HAD ANY BENEFICIAL EFFECT ON HER ANXIETY AND DEPRESSION. AS A RESULT, THE PATIENT ULTIMATELY ELECTED TO UNDERGO ELECTROCONVULSIVE THERAPY (ECT); SHE UNDERWENT 8 BILATERAL ECT TREATMENTS, THREE TIMES PER WEEK. AFTER THE THIRD ECT TREATMENT, THE PATIENT BEGAN TO SHOW A REDUCTION IN ANXIETY AND DEPRESSION. HOWEVER, AFTER HER FOURTH ECT TREATMENT, SHE EXPERIENCED MILD SHORT-TERM MEMORY PROBLEMS AND THE DURATION OF ECT WAS DECREASED FROM 4 TO 3. OVER THE COURSE OF ECT AND 1 WEEK SUBSEQUENT TO TREATMENT, SHE DEMONSTRATED COMPLETE RESOLUTION OF DEPRESSION AND EXPERIENCED MINIMAL ANXIETY. SHE ALSO EXPERIENCED A MODEST IMPROVEMENT IN HER PARKINSONISM, NOTABLY FEELING NIMBLER WITH A MORE FLUID GATE. HER QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY SCORES DROPPED FROM 11 TO 4 AT THE END OF HER ECT TREATMENT COURSE. HER PARKINSONISM CONTINUED TO BE CONTROLLED AND SHE REMAINED EUTHYMIC WITHOUT MEDICATIONS FOR 10 MONTHS. PROGRESSIVELY HOWEVER, SHE BEGAN TO EXPERIENCE SLEEP DISTURBANCE, WORSENING ANXIETY, ONSET OF DEPRESSION AND INTRUSIVE THOUGHTS, AND VAGUE SUICIDAL IDEATION. STILL INTOLERANT OF MEDICATIONS, SHE UNDERWENT ANOTHER COURSE OF ECT FOLLOWING A SIMILAR PROCEDURE AS HER FIRST COURSE. AGAIN, THE PATIENT EXPERIENCED A COMPLETE RESOLUTION OF DEPRESSION AND ANXIETY WITH NOTABLE IMPROVEMENT IN HER PARKINSONISM LASTING APPROXIMATELY 3 MONTHS. DEPRESSIVE SYMPTOMATOLOGY SCORES DROPPED FROM 17 TO 4 AT THE END OF THIS ECT TREATMENT COURSE. SHE HAS SINCE DEMONSTRATED A NEAR-YEARLY CYCLING INTO DEPRESSION AFTER A COURSE OF ECT. HAVING NOW RECEIVED THREE COURSES, THE PATIENT IS BEING PLACED ON A MAINTENANCE ECT SCHEDULE TO PREVENT RELAPSE. THE AUTHORS NOTED THAT THE MECHANISM OF THE PATIENT¿S MOOD CHANGE REMAINED POORLY UNDERSTOOD, BUT THEY ULTIMATELY HYPOTHESIZED THAT IT WAS ASSOCIATED WITH A SUDDEN ONSET OF STIMULATION DURING THE BATTERY CHANGE: ONE OF THE PATIENT¿S SETTINGS WAS PROGRAMMED IN THE ¿UNIPOLAR¿ MODE, WHICH USED THE PULSE GENERATOR AS THE CATHODE PORTION OF THE CIRCUIT, AND THE BATTERY HAD NOT BEEN TURNED OFF PRIOR TO IMPLANTATION. THEREFORE THE THERAPEUTIC CIRCUIT WAS ACTIVATED INSTANTANEOUSLY, WITHOUT DELAY, UPON CONTACT OF THE PULSE GENERATOR WITH THE PATIENT¿S TISSUE, AND THE FULL THERAPEUTIC STIMULATION WAS DELIVERED WITHOUT ANY BUFFERING RAMP-UP DELAY. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL SPECIFIC DEVICE INFORMATION (E.G. SERIAL NUMBERS) FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864242 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R