BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2527405 · Received April 11, 2012

    Report

    Report Number
    3007566237-2012-00725
    Event Type
    Injury
    Date Received
    April 11, 2012
    Report Date
    April 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: CHANG, W.S., KIM, H.Y., KIM, J.P., PARK, Y.S., CHUNG, S.S., CHANG, J.W., BILATERAL SUBTHALAMIC DEEP BRAIN STIMULATION USING SINGLE TRACK MICROELECTRODE RECORDING, ACTA NEUROCHIRURGICA, VOLUME 153 (2011). DOI 10.1007/S00701-011-0953-1. SUMMARY: MICROELECTRODE RECORDING (MER) IS WIDELY USED DURING DEEP BRAIN STIMULATION (DBS) PROCEDURES BECAUSE MER CAN IDENTIFY STRUCTURAL BORDERS AND ELOQUENT STRUCTURES, LOCALIZE SOMATOTOPIC ARRANGEMENTS, AND PROVIDE AN OUTLINE OF THE THREE-DIMENSIONAL SHAPES OF TARGET NUCLEI. HOWEVER, MER MAY CAUSE INTRACRANIAL HEMORRHAGE. WE PREFORMED SINGLE TRACK MER DURING DBS PROCEDURES, ANALYZED THE ACCURACY OF ELECTRODE POSITIONING WITH MRI, AND COMPARED THE AMOUNT OF AIR AND THE POTENTIAL RISK OF INTRACRANIAL HEMORRHAGE. A TOTAL OF 46 ELECTRODES WERE PLACED IN 23 PATIENTS WHO SUFFERED FROM ADVANCED PARKINSON'S DISEASE AND WHO UNDERWENT BILATERAL SUBTHALAMIC NUCLEUS DBS USING SINGLE TRACK MER. THE ACCURACY OF ELECTRODE POSITIONING APPEARS TO BE ACCEPTABLE UNDER SINGLE TRACK MER DURING STN DBS WITH CAREFUL ELECTROPHYSIOLOGICAL AND NEUROLOGICAL MONITORING. THE RISK OF INTRACRANIAL HEMORRHAGE APPEARS TO BE MINIMAL, ESPECIALLY IN ELDERLY PATIENTS WITH ATROPHIC BRAINS. REPORTED EVENTS: INTRACRANIAL HEMORRHAGE OCCURRED IN ONE PATIENT, A (B)(6) FEMALE WHO HAD SUFFERED FROM SEVERE RIGIDITY, BRADYKINESIA, AND RESTING TREMORS FOR 6 YEARS. POSTOPERATIVE MRI SHOWED NO EVIDENCE OF INTRACRANIAL HEMORRHAGE, AND THE PATIENT HAD NO SYMPTOMS OR SIGNS OF A NEUROLOGICAL ABNORMALITY. SIX HOURS AFTER SURGERY, THE PATIENT DEVELOPED A GENERAL TONIC-CLONIC SEIZURE, AND COMPUTED TOMOGRAPHY (CT) SHOWED A HEMORRHAGE IN THE RIGHT FRONTAL SUBCORTICAL AREA. VENOUS INFARCTION WAS THOUGHT TO BE THE CAUSE OF THE HEMORRHAGE BECAUSE THE HEMORRHAGE WAS CLOSER TO THE SURFACE OF THE BRAIN THAN THE PASSAGE OR TIP OF ELECTRODE. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention