BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 5493434 · Received March 10, 2016

    Report

    Report Number
    3007566237-2016-01350
    Event Type
    Injury
    Date Received
    March 10, 2016
    Date of Event
    January 8, 2016
    Report Date
    February 11, 2016
    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 THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. SECTION INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    PARK, H.R., LEE, J.M., EHM, G., YANG, H-J., SONG, I.H., LIM, Y.H., KIM, M-R., KIM, K.R., LEE, W-W., KIM, Y.E., HWANG, J.H., SHIN, C.W., PARK, H., KIM, J.W., KIM, H-J., KIM, C., KIM, D.G., JEON, B.W., PAEK, S.H. LONG-TERM CLINICAL OUTCOME OF INTERNAL GLOBUS PALLIDUS DEEP BRAIN STIMULATION FOR DYSTONIA. PLOS ONE. 2016;11(1):E0146644. DOI: DOI:10.1371/JOURNAL.PONE.0146644. SUMMARY: GPI (INTERNAL GLOBUS PALLIDUS) DBS (DEEP BRAIN STIMULATION) IS RECOGNIZED AS A SAFE, RELIABLE, REVERSIBLE AND ADJUSTABLE TREATMENT IN PATIENTS WITH MEDICALLY REFRACTORY DYSTONIA. THIS REPORT DESCRIBES THE LONG-TERM CLINICAL OUT COME OF 36 PATIENTS IMPLANTED WITH GPI DBS AT THE NEUROSURGERY DEPARTMENT OF (B)(6) HOSPITAL. REPORTED EVENTS: 1. ONE PATIENT WITH MEDICALLY REFRACTORY DYSTONIA WHO WAS IMPLANTED WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) EXPERIENCED AN "INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTATION SITE." IT WAS NOTED THE PATIENT'S INS WAS REMOVED AS A RESULT OF THE EVENT. THE PATIENT WAS REIMPLANTED AT A LATER DATE AND "THE PATIENT'S DYSTONIC SYMPTOMS IMPROVED." 2. ONE PATIENT WITH MEDICALLY REFRACTORY DYSTONIA WHO WAS TO BE IMPLANTED WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) EXPERIENCED A "FAILED SURGERY DUE TO AN INTRACRANIAL HEMORRHAGE DURING LEAD INSERTION." ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING PATIENT/DEVICE INFO, EVENT DATES, CLARIFICATION ON THE INFORMATION PROVIDED, AND FOR ADDITIONAL MISSING REQUIRED FIELDS; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147778 SOLETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7426 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention