BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4151702 · Received October 8, 2014

    Report

    Report Number
    3007566237-2014-02875
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE DEVICE WAS USED TO TREAT TOURETTE SYNDROME. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    SACHDEV, P.S., MOHAN, A., CANNON, E., CRAWFORD, J.D., SILBERSTEIN, P., COOK, R. COYNE, T. SILBURN, P.A. DEEP BRAIN STIMULATION OF THE ANTERO-MEDIAL GLOBUS PALLIDUS INTERNA FOR TOURETTE SYNDROME. PLOS ONE. 2014;9(8):E104926. DOI:10.1371/JOURNAL.PONE.0104926 SUMMARY: WE HAVE PREVIOUSLY REPORTED THE RESULTS OF DEEP BRAIN STIMULATION (DBS) OF THE ANTERO-MEDIAL GLOBUS PALLIDUS INTERNA (GPI) FOR SEVERE TOURETTE SYNDROME (TS) IN 11 PATIENTS. WE EXTEND THIS CASE SERIES TO 17 PATIENTS AND A LONGER FOLLOWUP TO A MAXIMUM OF 46 MONTHS. SEVENTEEN PATIENTS (14 MALE; MEAN AGE 29.1 YEARS, RANGE 17¿51 YEARS) WITH SEVERE AND MEDICALLY INTRACTABLE TS WERE IMPLANTED WITH MEDTRONIC QUADRIPOLAR ELECTRODES BILATERALLY IN THE ANTERO-MEDIAL GPI. THE PRIMARY OUTCOME MEASURE WAS THE YALE GLOBAL TIC SEVERITY SCALE (YGTSS). SECONDARY OUTCOME MEASURES INCLUDED THE YALE-BROWN OBSESSIVE COMPULSIVE SCALE, HAMILTON DEPRESSION RATING SCALE, GILLES DE LA TOURETTE QUALITY OF LIFE SCALE AND GLOBAL ASSESSMENT OF FUNCTIONING. FOLLOW UP WAS AT ONE MONTH, THREE MONTHS AND FINALLY AT A MEAN 24.1 MONTHS (RANGE 8¿46 MONTHS) FOLLOWING SURGERY. OVERALL, THERE WAS A 48.3% REDUCTION IN MOTOR TICS AND A 41.3% REDUCTION IN PHONIC TICS AT ONE MONTH, AND THIS IMPROVEMENT WAS MAINTAINED AT FINAL FOLLOW-UP. 12 OUT OF 17 (70.6%) PATIENTS HAD A.50% REDUCTION IN YGTSS SCORE AT FINAL FOLLOW UP. ONLY 8 PATIENTS REQUIRED ONGOING PHARMACOTHERAPY FOR TICS POST-SURGERY. PATIENTS IMPROVED SIGNIFICANTLY ON ALL SECONDARY MEASURES. ADVERSE CONSEQUENCES INCLUDED LEAD BREAKAGE IN 4 PATIENTS, INFECTION (1), TRANSIENT ANXIETY (2), DIZZINESS (1), POOR BALANCE (1) AND WORSENING OF STUTTERING (1). THIS CASE SERIES PROVIDES FURTHER SUPPORT THAT ANTERO-MEDIAL GPI DBS IS AN EFFECTIVE AND WELL TOLERATED TREATMENT FOR A SUBGROUP OF SEVERE TS, WITH BENEFITS SUSTAINED UP TO 4 YEARS. REPORTED EVENTS: A (B)(6) MALE HAD A RELAPSE OF SUBSTANCE ABUSE AND SUBSEQUENTLY HAD THE DEVICE EXPLANTED. IT WAS NOTED THAT THIS PATIENT WAS A TREATMENT RESPONDER AT THE END OF THE FIRST WAVE FOLLOW UP PERIOD, BUT HAD A DEVICE BATTERY FAILURE ASSOCIATED WITH A SEVERE TIC REOCCURRENCE AND A RELAPSE OF PRE-DBS PATTERN OF SUBSTANCE ABUSE. FAMILY DISCORD CULMINATED IN AN ACUTE PSYCHIATRIC ADMISSION. THE PATIENT HAD THE DEVICE EXPLANTED IN THE AFTERMATH OF THESE EVENTS. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: EITHER A SOLETRA (MODEL 7426 OR AN ACTIVA PC/RC (MODEL 37601/37612) DEVICE WAS USED; AND A MODEL 3389 LEAD WAS USED. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633583 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Hospitalization| R