BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 6615218 · Received June 6, 2017

    Report

    Report Number
    3007566237-2017-02194
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    April 17, 2017
    Report Date
    June 6, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 7426, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PARK HR, LEE JM, EHM G, YANG HJ, SONG IH, LIM YH, KIM MR, KIM KR, LEE WW, KIM YE, HWANG JH, SHIN CW, PARK H, KIM JW, KIM HJ, KIM C, KIM DG, JEON BS, PAEK SH. CORRELATION OF ELECTRODE POSITION AND CLINICAL OUTCOMES IN GLOBUS PALLIDUS STIMULATION FOR DYSTONIA. ACTANEUROCHIR (2017) DOI: 10.1007/S00701-017-3182-4. ABSTRACT: THE CORRELATION BETWEEN THE ELECTRODE LOCATION AND THE CLINICAL OUTCOME FOR INTERNAL GLOBUS PALLIDUS (GPI) DEEP BRAIN STIMULATION (DBS) HAS NOT BEEN FULLY ELUCIDATED. THE AIM OF THIS STUDY WAS TO DETERMINE THE DISCREPANCIES BETWEEN THE THEORETICAL TARGET PLANNED BY MAGNETIC RESONANCE IMAGING (MRI) AND THE ACTUAL ELECTRODE LOCATION IN POSTOPERATIVE MRI, AS WELL AS TO FIND THE CORRELATION BETWEEN THE FINAL ELECTRODE LOCATIONS AND THE CLINICAL OUTCOME AFTER GPI DBS. THIRTY-SIX PATIENTS WHO UNDERWENT GPI DBS FOR DYSTONIA WERE INCLUDED IN THIS RETROSPECTIVE STUDY. THE X COORDINATE WAS DEFINED AS THE LATERAL DISTANCE FROM THE MIDLINE, THE Y COORDINATE AS THE ANTERIOR DISTANCE FROM THE MID-COMMISSURAL POINT, AND THE Z COORDINATE AS THE INFERIOR DISTANCE FROM THE INTERCOMMISSURAL LINE. ALL COORDINATES SHOWED A SIGNIFICANT DIFFERENCE BETWEEN THEORETICAL AND ACTUAL VALUES FOR ALL ELECTRODE LOCATIONS. IN PARTICULAR, GREATER DIFFERENCES WERE EXHIBITED FOR Y THAN FOR THE X AND Z COORDINATES. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE ACCURACY OF THE LOCALIZATION OF THE LEFT-SIDE VERSUS THE RIGHT-SIDE ELECTRODE FOR ANY COORDINATES. THE PATIENTS WHOSE ELECTRODES WERE LOCATED WITHIN OR NEAR THE POSTEROVENTRAL GPI SHOWED BETTER CLINICAL OUTCOMES. THE ACTUAL ELECTRODE LOCATION WAS SLIGHTLY MORE POSTERIOR TO THE THEORETICALLY PLANNED TARGET. ELECTRODES CONCENTRATED NEAR THE POSTEROVENTRAL GPI TENDED TO YIELD FAVORABLE OUTCOMES. REPORTED EVENTS: 1. ONE PATIENT WITH INTERNAL GLOBUS PALLIDUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF DYSTONIA EXPERIENCED IMPLANTABLE NEUROSTIMULATOR (INS) SITE INFECTION, WHICH REQUIRED INS REMOVAL. THE INS WAS RE-INSERTED AND THE PATIENT¿S DYSTONIC SYMPTOMS IMPROVED. 2. ONE MALE PATIENT WITH INTERNAL GLOBUS PALLIDUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF DYSTONIA EXPERIENCED IMPLANTABLE NEUROSTIMULATOR (INS) SITE INFECTION, WHICH REQUIRED INS REMOVAL. THE INFECTION WAS NOTED TO BE SUSTAINED. THE PATIENT LATER UNDERWENT A BILATERAL PALLIDOTOMY AND THEN SHOWED MARKEDLY IMPROVED MOVEMENT AND DAILY ACTIVITY. 3. ONE PATIENT WITH INTERNAL GLOBUS PALLIDUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF DYSTONIA EXPERIENCED A HEMORRHAGE DURING THE LEAD INSERTION STEP OF THE SURGICAL PROCEDURE. THE PROCEDURE WAS STOPPED. THE PATIENT RECOVERED WITH MINIMAL NEUROLOGICAL SEQUELAE AND UNDERWENT THE DBS PROCEDURE SUCCESSFULLY 18 MONTHS LATER. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3387; IMPLANTABLE NEUROSTIMULATOR SOLETRA MODEL 7426.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396183 SOLETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7426 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention