BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1658303 · Received April 12, 2010

    Report

    Report Number
    3007566237-2010-02939
    Event Type
    Injury
    Date Received
    April 12, 2010
    Date of Event
    February 28, 2010
    Report Date
    March 12, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    LITERATURE: MORO E, HAMANI C, POON YY, ET AL. UNILATERAL PEDUNCULOPONTINE STIMULATION IMPROVES FALLS IN PARKINSON'S DISEASE. BRAIN . JAN; 133 (PT 1): 215-224. SUMMARY: THIS WAS AN EVALUATION OF PPN DBS IN SIX PATIENTS WITH INTRA-OPERATIVE NEUROPHYSIOLOGICAL AND POSTOPERATIVE IMAGING CHARACTERIZATION OF THE SURGICAL TARGET. THE AIM OF THIS PROSPECTIVE STUDY WAS TO INVESTIGATE THE SAFETY AND THE EFFECTS OF UNILATERAL PPN DBS ON MOTOR SIGNS, ESPECIALLY FALLS, FREEZING OF GAIT AND POSTURAL STABILITY IN PATIENTS WITH ADVANCED PARKINSON'S DISEASE. EVENT: ONE PATIENT HAD THE ELECTRODE REPOSITIONED 4 MONTHS AFTER THE INITIAL IMPLANT DUE TO VERY LOW THRESHOLD OF STIMULATION-INDUCED PARESTHESIAS AND THE LACK OF ANY MOTOR IMPROVEMENT.

    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 Required Intervention LEAD: MODEL 3387, LOT# UNK| EXPLANTED:| IMPLANTED: