BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4409913 · Received January 12, 2015

    Report

    Report Number
    3007566237-2015-00096
    Event Type
    Injury
    Date Received
    January 12, 2015
    Report Date
    December 15, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ZHANG, J.G., GE, Y., STEAD, M., ZHANG, K., YAN, S.S., HU, W., MENG, F.G. LONG-TERM OUTCOME OF GLOBUS PALLIDUS INTERNUS DEEP BRAIN STIMULATION IN PATIENTS WITH TOURETTE SYNDROME. MAYO CLINIC PROCEEDINGS. 2014;89(11):1506-1514. DOI: 10.1016/J.MAYOCP.2014.05.019 SUMMARY: TO EVALUATE THE EFFECTIVENESS OF DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) ON TIC SEVERITY AND COMMON COMORBIDITIES IN PATIENTS WITH SEVERE TOURETTE SYNDROME THAT IS REFRACTORY TO PHARMACOLOGICAL TREATMENT AND PSYCHOTHERAPY. WE RETROSPECTIVELY ASSESSED THE LONG-TERM CLINICAL OUTCOMES OF 13 PATIENTS WITH TREATMENT-REFRACTORY TOURETTE SYNDROME WHO UNDERWENT DBS TARGETING THE GPI AT THE BEIJING TIANTAN HOSPITAL FROM JANUARY 1, 2006, THROUGH MAY 31, 2013. THE PRIMARY OUTCOME WAS A CHANGE IN TIC SEVERITY AS MEASURED BY THE YALE GLOBAL TIC SEVERITY SCALE, AND THE SECONDARY OUTCOME WAS A CHANGE IN ASSOCIATED BEHAVIORAL DISORDERS AND MOOD AS MEASURED BY THE GILLES DE LA TOURETTE SYNDROME QUALITY OF LIFE SCALE ASSESSMENT. COMPARED WITH BASELINE, THE MEAN REDUCTION IN THE TOTAL YALE GLOBAL TIC SEVERITY SCALE SCORES AT LAST FOLLOW-UP (MEAN, 41.9 MONTHS; RANGE, 13-80 MONTHS) WAS 52.1% (RANGE, 4.3%-83.6%), AND THE MEAN IMPROVEMENT RATES AT 1 MONTH, 6 MONTHS, 12 MONTHS, 18 MONTHS, 24 MONTHS, 30 MONTHS, AND 36 OR MORE MONTHS WERE 11.8%, 20.0%, 26.8%, 36.7%, 44.7%, 49.0%, AND 56.7%, RESPECTIVELY. A PAIRED-SAMPLE T TEST REVEALED SIGNIFICANT IMPROVEMENT OF TIC SYMPTOMS AFTER 6 MONTHS OF DBS PROGRAMMING (P<(><<)>.05). THE GILLES DE LA TOURETTE SYNDROME QUALITY OF LIFE SCALE SCORE IMPROVED BY A MEAN OF 45.7% (RANGE, 11.0%-77.2%). THIS STUDY IS CURRENTLY THE LARGEST REPORTED GPI DBS CASE SERIES OF PATIENTS WITH TREATMENT REFRACTORY TS WITH THE LONGEST FOLLOW-UP. OUR RESULTS SUPPORT THE POTENTIAL BENEFICIAL EFFECT OF GPI DBS ON DISABLING TIC REDUCTION AND IMPROVEMENT OF QUALITY OF LIFE. REPORTED EVENT: A (B)(6) MALE WITH TOURETTE SYNDROME EXPERIENCED CHEST SUBCUTANEOUS HYDROPS AND SIGNS OF INFECTION ON THE CHEST 3 YEARS POSTOPERATIVELY. FURTHERMORE, THE PATIENT EXPERIENCED ANXIETY AFTER IMPLANTATION, AND THE SYMPTOMS WERE RESOLVED WITH CAREFUL REPROGRAMMING. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD "BEEN RECEIVED" ADEQUATE THERAPY AND "ALMOST FULLY RECOVERED."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REGARDING THIS EVENT RECEIVED FROM THE AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25041 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Required Intervention