BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7700742 · Received July 18, 2018

    Report

    Report Number
    3007566237-2018-02145
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    January 1, 2017
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE YEAR OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD. ASCENCAO, L.C., VAN EGMOND, M.E., OTERDOOM, M., SARYYEVA, A., RUNGE, J., ABDALLAT, M., TIJSSEN, M.A.J., KRAUSS, J.K. IMPROVEMENT OF DYSTONIC STORM AFTER RELOCATION OF PALLIDAL ELECTRODES IN DYT-6 POSITIVE GENERALIZED DYSTONIA. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY (2017) 95 SUPPLEMENT 1 (201). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SUMMARY/REPORTED EVENT: AN (B)(6) BOY WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF DYT-6 POSITIVE GENERALIZED DYSTONIA SINCE 2 YEARS PRIOR DEVELOPED SEVERE DYSTONIC STORM. AFTER IMPLANTATION OF DBS ELECTRODES AT (B)(6) HIS CONDITION HAD IMPROVED FOR MORE THAN 2 YEARS. UPON THE OCCURRENCE OF DYSTONIC STORM, RE-PROGRAMING OF DBS COULD NOT AMELIORATE THE SEVERE STATUS DYSTONICS. ONLY SEDATION WITH HIGH DOSE BENZODIAZEPINES, BACLOFEN, GABAPENTIN AND TRIHEXYPHENIDYL RESULTED IN TRANSIENT IMPROVEMENT. RESULTS: THE BMFDR MOTOR SCORE ON ADMISSION WAS 138. MRI IMAGING SHOWED POSITIONING OF THE DBS ELECTRODES IN THE GLOBUS PALLIDUS INTERNUS (GPI), HOWEVER, MORE LATERAL AND POSTERIOR THAN AT THE USUAL TARGET. IT WAS DECIDED TO REIMPLANT THE GPI ELECTRODES AND TO IMPLANT THALAMIC VIM ELECTRODES IN ADDITION. EARLY POSTOPERATIVELY THIS RESULTED IN MARKED AND IMMEDIATE IMPROVEMENT OF DYSTONIC STORM (BMFDRS 100,5). AT 12-MONTH FOLLOW-UP, THERE WAS REMARKABLE BENEFIT AND THE PATIENT COULD WALK AND ATTEND SCHOOL WITHOUT MEDICATION. CONCLUSION: DYSTONIC STORM MAY DEVELOP DESPITE PERIODS OF BENEFICIAL RESPONSE TO PALLIDAL DBS FOR SEVERAL YEARS. IF ELECTRODES ARE NO OPTIMALLY PLACED IN THE POSTEROVENTRAL LATERAL GPI, REPOSITIONING SHOULD BE CONSIDERED, WHICH MIGHT NOT ONLY ABATE STATUS DYSTONICS, BUT ALSO PROVIDE LASTING BENEFITS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543168 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening| R