BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3007566237-2016-01605

    MDR report key: 5550368 · Received April 6, 2016

    Report

    Report Number
    3007566237-2016-01605
    Event Type
    Injury
    Date Received
    April 6, 2016
    Date of Event
    September 1, 2009
    Report Date
    April 6, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MFR
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE MONTH THE PATIENT WAS IMPLANTED AS THE SPECIFIC DATE OF IMPLANT WAS NOT PROVIDED IN THE PUBLISHED LITERATURE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REAL, E., PLANS, G., ALONSO, P., APARICIO, M.A., SEGALAS, C., CARDONER, N., SORIANO-MAS, C., LÓPEZ-SOLÀ, C., MENCHÓN, J.M. REMOVING AND REIMPLANTING DEEP BRAIN STIMULATION THERAPY DEVICES IN RESISTANT OCD (WHEN THE PATIENT DOES NOT RESPOND): CASE REPORT. BMC PSYCHIATRY. 2016;16(1):26. DOI:10.1186/S12888-016-0730-Z SUMMARY: DEEP BRAIN STIMULATION (DBS) IS EMERGING AS A PROMISING TOOL IN THE TREATMENT OF REFRACTORY OBSESSIVE-COMPULSIVE DISORDER (OCD) BUT THE SEARCH FOR THE BEST TARGET STILL CONTINUES. THIS ISSUE IS ESPECIALLY RELEVANT WHEN PARTICULARLY RESISTANT PROFILES ARE OBSERVED IN SOME PATIENTS, WHICH HAVE BEEN ASCRIBED TO INDIVIDUAL RESPONSES TO DBS ACCORDING TO DIFFERENTIAL PATTERNS OF CONNECTIVITY. AS PATIENTS HAVE BEEN IMPLANTED, NEW DILEMMAS HAVE EMERGED, SUCH AS WHAT TO DO WHEN THE PATIENT DOES NOT RESPOND TO SURGERY. REPORTED EVENT: A (B)(6) MALE WHO RECEIVED A BILATERAL DEEP BRAIN STIMULATION (DBS) SYSTEM TARGETING THE NUCLEUS ACCUMBENS FOR OBSESSIVE COMPULSIVE DISORDER (OCD) IN (B)(6) 2009 REPORTEDLY RECEIVED NO SIGNIFICANT CLINICAL IMPROVEMENT FROM THE DEVICE THERAPY. THE AUTHORS REPORTED A YALE-BROWN OBSESSIVE-COMPULSIVE SCALE (Y-BOCS) SCORE REDUCTION FROM 38 TO 35, A LESS THAN 10 % IMPROVEMENT. THE PATIENT¿S QUALITY OF LIFE REMAINED VERY POOR, AND HE NEEDED FURTHER HOSPITAL ADMISSIONS AFTER DBS SURGERY DESPITE ¿PARAMETER TESTING AND ADJUSTMENT [BEING] THE SAME AS IN OTHER DBS IMPLANTED PATIENTS.¿ AFTER A FULL EXPLANATION AND WITH THE CONSENT OF THE PATIENT AND HIS FAMILY, THE DBS ELECTRODES WERE REMOVED IN (B)(6) 2011. THE AUTHORS NOTED THAT THE PATIENT LATER RESPONDED TO A SECOND PAIR OF DBS LEADS IMPLANTED IN (B)(6) 2011 THAT TARGETED THE CENTRAL CAPSULE/VENTRAL STRIATUM. IT WAS NOTED THAT THE PATIENT WAS BILATERALLY IMPLANTED WITH MODEL 3389 LEADS, BUT THE MODEL OF NEUROSTIMULATOR WAS NOT REPORTED. 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. FOLLOW-UP TO THE ARTICLE¿S CORRESPONDING AUTHOR HAS BEEN REQUESTED FOR ADDITIONAL/MISSING EVENT INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205096 MFR MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Hospitalization