BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2190344 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05668
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    February 23, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(6).

    Description of Event or Problem · 1

    LITERATURE: MORO E, SCHWALB JM, PIBOOLNURAK P, ET AL. UNILATERAL SUBDURAL MOTOR CORTEX STIMULATION IMPROVES ESSENTIAL TREMOR BUT NOT PARKINSON'S DISEASE. BRAIN. JUL 2011;134 (PT 7):2096-2105. SUMMARY: THIS STUDY LOOKED AT THE EFFICACY AND SAFETY OF UNILATERAL SUBDURAL MOTOR CORTEX STIMULATION IN SIX PATIENTS WITH ESSENTIAL TREMOR (ET) AND FIVE PATIENTS WITH ADVANCED PARKINSON'S DISEASE (PD) BETWEEN (B)(6) 2004 AND (B)(6) 2006. PATIENTS WERE ASSESSED DURING ACUTE, INTERMEDIATE AND CHRONIC (B)(6) STIMULATION. PRIMARY OUTCOME MEASURES IN PATIENT WITH ET WERE CHANGES IN TREMOR SCORES AT (B)(6) AND IN PATIENTS WITH PD CHANGES IN (B)(6) MOTOR SCORES AT 3 MONTHS IN OFF MEDICATION/ON STIMULATION VERSUS OFF MEDICATION/OFF STIMULATION AND ON MEDICATION/OFF STIMULATION VERSUS ON MEDICATION/ON STIMULATION CONDITIONS. REPORTABLE EVENT: A (B)(6) MALE PATIENT WITH PD WHO WAS TAKING PROPRANOLOL AND PRIMIDONE EXPERIENCED A CORTICAL VENOUS INFARCTION DURING SURGERY WITH CONSEQUENT PERMANENT SPASTIC RIGHT HEMIPARESIS AND APHASIA. STIMULATION WAS STARTED APPROXIMATELY 2 MONTHS AFTER SURGERY WHEN THE PATIENT HAD OBTAINED APPROXIMATELY 70% RECOVERY IN THE MOTOR FUNCTIONAL DISABILITY, WHICH ALLOWED RELIABLE TESTING. THE PATIENT, HOWEVER, EXPERIENCED LOW-VOLTAGE THRESHOLD INDUCED MOTOR SEIZURES. TESTING WAS NOT FULLY EXPLORED DUE TO THE PATIENT'S POOR COMPLIANCE WITH ANTI-EPILEPTIC MEDICATIONS. TWO MONTHS AFTER THE DOUBLE-BLIND ASSESSMENT, THE PATIENT HAD THE STIMULATOR SWITCHED OFF DUE TO THE BELIEF THAT THE STIMULATION WAS WORSENING THE PATIENT'S MOTOR FUNCTION. AT THE ONE-YEAR FOLLOW-UP, THE STIMULATION WAS TURNED ON TO ALLOW ASSESSMENT, BUT WAS THEN TURNED OFF AGAIN AND LEFT OFF. THE ONE YEAR FOLLOW-UP SHOWED A WORSENING OF THE TOTAL MOTOR UPDRS SCORES IN BOTH: THE OFF MEDICATION/ON STIMULATION CONDITION COMPARED WITH THE OFF MEDICATION CONDITION BEFORE SURGERY AND THE ON MEDICATION/ON STIMULATION CONDITION COMPARED WITH THE ON MEDICATION CONDITION BEFORE SURGERY. THE TOTAL UPDRS-II SCORE ALSO WORSENED BOTH IN THE ON AND OFF MEDICATION CONDITIONS AT THE ONE YEAR FOLLOW-UP. THE LEVODOPA EQUIVALENT DAILY DOSE WAS SLIGHTLY INCREASED AT 1 YEAR AS COMPARED TO 3 MONTHS AND BEFORE SURGERY. THE PATIENT CONTINUED TO DETERIORATE COGNITIVELY, MEETING THE CRITERIA FOR DEMENTIA 1.5 YEARS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| S IMPLANTED:| LEAD: MODEL 3587A, LOT# UNKNOWN| EXPLANTED: