BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 7064048 · Received November 28, 2017

    Report

    Report Number
    3007566237-2017-04973
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    June 20, 2017
    Report Date
    November 28, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED PMA/510(K) NUMBER TO P960009 FROM H050003 (ALTHOUGH THE DEVICE WAS USED OFF-LABEL) IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION; SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_ INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3389 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3389 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3389 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR H10: WELTER, ML., HOUETO, JL., THOBOIS, S., BATAILLE, B., GUENOT, M., WORBE, Y., HARTMANN, A., CZERNECKI, V., BARDINET, E., YELNIK, J., TEZENAS DU MONTCEL, S., AGID, Y., VIDAILHET, M., CORNU, P., TANGUY, A., ANSQUER, S., JAAFARI, N., POULET, E., SERRA, G., BURBAUD, P., CUNY, E., AOUIZERATE, B., POLLAK, P., CHABARDES, S., POLOSAN, M., FONTAINE, D., GIORDANA, B., RAOUL, S., ROUAUD, T., SAUVAGET, A., JALENQUES, I., KARACHI, C., MALLET, L. ANTERIOR PALLIDAL DEEP BRAIN STIMULATION FOR TOURETTE'S SYNDROME: A RANDOMISED, DOUBLE-BLIND, CONTROLLED TRIAL. LANCET NEUROL. 2017;16(8):610-619. DOI: 10.1016/S1474-4422(17)30160-6.

    Description of Event or Problem · 1

    SUMMARY: DEEP BRAIN STIMULATION (DBS) HAS BEEN PROPOSED TO TREAT PATIENTS WITH SEVERE TOURETTE¿S SYNDROME, AND OPEN-LABEL TRIALS AND TWO SMALL DOUBLE-BLIND TRIALS HAVE TESTED DBS OF THE POSTERIOR AND THE ANTERIOR INTERNAL GLOBUS PALLIDUS (AGPI). WE AIMED TO SPECIFICALLY ASSESS THE EFFICACY OF AGPI DBS FOR SEVERE TOURETTE¿S SYNDROME. METHODS IN THIS RANDOMISED, DOUBLE-BLIND, CONTROLLED TRIAL, WE RECRUITED PATIENTS AGED 18¿60 YEARS WITH SEVERE AND MEDICALLY REFRACTORY TOURETTE¿S SYNDROME FROM EIGHT HOSPITALS SPECIALISED IN MOVEMENT DISORDERS IN (B)(6). ENROLLED PATIENTS RECEIVED SURGERY TO IMPLANT BILATERAL ELECTRODES FOR AGPI DBS; 3 MONTHS LATER THEY WERE RANDOMLY ASSIGNED (1:1 RATIO WITH A BLOCK SIZE OF EIGHT; COMPUTER-GENERATED PAIRWISE RANDOMISATION ACCORDING TO ORDER OF ENROLMENT) TO RECEIVE EITHER ACTIVE OR SHAM STIMULATION FOR THE SUBSEQUENT 3 MONTHS IN A DOUBLE-BLIND FASHION. ALL PATIENTS THEN RECEIVED OPEN-LABEL ACTIVE STIMULATION FOR THE SUBSEQUENT 6 MONTHS. PATIENTS AND CLINICIANS ASSESSING OUTCOMES WERE MASKED TO TREATMENT ALLOCATION; AN UNMASKED CLINICIAN WAS RESPONSIBLE FOR STIMULATION PARAMETER PROGRAMMING, WITH INTENSITY SET BELOW THE SIDE-EFFECT THRESHOLD. THE PRIMARY ENDPOINT WAS DIFFERENCE IN YALE GLOBAL TIC SEVERITY SCALE (YGTSS) SCORE BETWEEN THE BEGINNING AND END OF THE 3-MONTH DOUBLE-BLIND PERIOD, AS ASSESSED WITH A MANN- WHITNEY-WILCOXON TEST IN ALL RANDOMLY ALLOCATED PATIENTS WHO RECEIVED ACTIVE OR SHAM STIMULATION DURING THE DOUBLE-BLIND PERIOD. WE ASSESSED SAFETY IN ALL PATIENTS WHO WERE ENROLLED AND RECEIVED SURGERY FOR A GPI DBS. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV, NUMBER (B)(6). FINDINGS BETWEEN DEC 6, 2007, AND DEC 13, 2012, WE ENROLLED 19 PATIENTS. WE RANDOMLY ASSIGNED 17 (89%) PATIENTS, WITH 16 COMPLETING BLINDED ASSESSMENTS (SEVEN [44%] IN THE ACTIVE STIMULATION GROUP AND NINE [56%] IN THE SHAM STIMULATION GROUP). WE NOTED NO SIGNIFICANT DIFFERENCE IN YGTSS SCORE CHANGE BETWEEN THE BEGINNING AND THE END OF THE 3 MONTH DOUBLE-BLIND PERIOD BETWEEN GROUPS (ACTIVE GROUP MEDIAN YGTSS SCORE 68·5 [IQR 34·0 TO 83·5] AT THE BEGINNING AND 62·5 [51·5 TO 72·0] AT THE END, MEDIAN CHANGE 1·1% [IQR ¿23·9 TO 38·1]; SHAM GROUP 73·0 [69·0 TO 79·0] AND 79·0 [59·0 TO 81·5], MEDIAN CHANGE 0·0% [¿10·6 TO 4·8]; P=0·39). 15 SERIOUS ADVERSE EVENTS (THREE IN PATIENTS WHO WITHDREW BEFORE STIMULATION AND SIX EACH IN THE ACTIVE AND SHAM STIMULATION GROUPS) OCCURRED IN 13 PATIENTS (THREE WHO WITHDREW BEFORE RANDOMISATION, FOUR IN THE ACTIVE GROUP, AND SIX IN THE SHAM GROUP), WITH INFECTIONS IN DBS HARDWARE IN FOUR PATIENTS (TWO WHO WITHDREW BEFORE RANDOMISATION, ONE IN THE SHAM STIMULATION GROUP, AND ONE IN THE ACTIVE STIMULATION GROUP). OTHER SERIOUS ADVERSE EVENTS INCLUDED ONE ELECTRODE MISPLACEMENT (ACTIVE STIMULATION GROUP), ONE EPISODE OF DEPRESSIVE SIGNS (ACTIVE STIMULATION GROUP), AND THREE EPISODES OF INCREASED TIC SEVERITY AND ANXIETY (TWO IN THE SHAM STIMULATION GROUP AND ONE IN THE ACTIVE STIMULATION GROUP). INTERPRETATION 3 MONTHS OF A GPI DBS IS INSUFFICIENT TO DECREASE TIC SEVERITY FOR PATIENTS WITH TOURETTE¿S SYNDROME. FUTURE RESEARCH IS NEEDED TO INVESTIGATE THE EFFICACY OF AGPI DBS FOR PATIENTS OVER LONGER PERIODS WITH OPTIMAL STIMULATION PARAMETERS AND TO IDENTIFY POTENTIAL PREDICTORS OF THE THERAPEUTIC RESPONSE. REPORTED EVENTS: 1. PATIENT 7: THE (B)(6) MALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) OF THE ANTERIOR GLOBUS PALLIDUS INTERNUS (AGPI) FOR THE TREATMENT OF SEVERE TOURETTE¿S SYNDROME EXPERIENCED A TRANSIENT STIMULATION RELATED INCREASE IN TIC SEVERITY, ANXIETY, AS WELL AS DEPRESSIVE SYMPTOMS AND SUICIDAL THOUGHTS. THE AUTHORS NOTED THAT THESE SYMPTOMS RAPIDLY DISAPPEARED AFTER THE THERAPEUTIC CONTACTS WERE CHANGED. THE AUTHORS REPORTED THE PATIENT EXPERIENCED NO REDUCTION IN TIC SEVERITY OVER THE COURSE OF THE STUDY, AND STATED THAT THE PATIENTS¿ CHRONIC DEPRESSION, WHICH WAS ¿PROBABLY AGGRAVATED BY THE STIMULATION,¿ MAY HAVE LED TO A SMALLER DECREASE IN TIC SEVERITY THAN IF THE PATIENT DID NOT HAVE DEPRESSION. 2. PATIENT 5: THE (B)(6) FEMALE PATIENT WITH DBS OF THE AGPI FOR THE TREATMENT OF SEVERE TOURETTE¿S SYNDROME EXPERIENCED A SURGERY RELATED INFECTION LEADING TO THE REMOVAL OF THE STIMULATOR AND ELECTRODES. 3. PATIENT 15: THE (B)(6) MALE PATIENT WITH DBS OF THE AGPI FOR THE TREATMENT OF SEVERE TOURETTE¿S SYNDROME PATIENT EXPERIENCED A SURGERY RELATED INFECTION LEADING TO THE REMOVAL OF THE STIMULATOR AND ELECTRODES. 4. PATIENT 12: THE (B)(6) MALE PATIENT WITH DBS OF THE AGPI FOR THE TREATMENT OF SEVERE TOURETTE¿S SYNDROME EXPERIENCED A SURGERY RELATED INFECTION LEADING TO THE REMOVAL OF THE STIMULATOR AND ELECTRODES. THE DEVICE WAS REIMPLANTED AFTER REMOVAL. 5. PATIENT 12: THE (B)(6) MALE PATIENT WITH DBS OF THE AGPI FOR THE TREATMENT OF SEVERE TOURETTE¿S SYNDROME EXPERIENCED A REOCCURRENCE OF INFECTION WITH THE NEWLY IMPLANTED STIMULATOR DURING THE OPEN-LABEL PHASE OF THE STUDY, BUT THIS WAS SUCCESSFULLY TREATED WITH ANTIBIOTICS. THE AUTHORS SEPARATELY REPORTED THE PATIENT EXPERIENCED A SURGERY RELATED INFECTION AROUND THE HEAD SCAR AND IT REMAINS UNCLEAR HOW MANY INFECTIONS THE PATIENT EXPERIENCED DURING THE OPEN-LABEL PERIOD OF THE STUDY. 6. PATIENT 17: THE (B)(6) OLD FEMALE PATIENT WITH DBS OF THE AGPI FOR THE TREATMENT OF SEVERE TOURETTE¿S SYNDROME EXPERIENCED SEVERE TICS WITH HEAD TRAUMA AND FRONTAL HEMATOMA. 7. PATIENT 13: THE (B)(6) MALE PATIENT WITH DBS OF THE AGPI FOR THE TREATMENT OF SEVERE TOURETTE¿S SYNDROME EXPERIENCED A SURGERY RELATED INFECTION LEADING TO THE REMOVAL OF THE STIMULATOR AND ELECTRODES. 8. PATIENT 14: THE(B)(6) MALE PATIENT WITH DBS OF THE AGPI FOR THE TREATMENT OF SEVERE TOURETTE¿S SYNDROME EXPERIENCED MISPLACEMENT OF AN ELECTRODE LEADING TO REIMPLANTATION. THE AUTHORS REPORTED THAT ALL PATIENTS WERE IMPLANTED WITH EITHER SOLETRA MODEL 7426 OR KINETRA MODEL 7428 NEUROSTIMULATORS, AND MODEL 3389 LEADS, HOWEVER THEY DID NOT SPECIFY WHICH PATIENTS/EVENTS WERE ASSOCIATED WITH WHICH STIMULATOR. IT WAS NOT POSSIBLE TO ASCERTAIN ANY FURTHER SPECIFIC DEVICE INFORMATION 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
    842522 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| O| R