BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3200237 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-02168
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCT: PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    WANG, E. S., YAO, H. B., CHEN, Y. H., WANG, G., GAO, W-W., SUN, Y-R., GUO, J-G., HU, J-W., JIANG, C-C., HU, J. PROTEOMIC ANALYSIS OF THE CEREBROSPINAL FLUID OF PARKINSON'S DISEASE PATIENTS PRE- AND POST-DEEP BRAIN STIMULATION. CELLULAR PHYSIOLOGY AND BIOCHEMISTRY: INTERNATIONAL JOURNAL OF EXPERIMENTAL CELLULAR PHYSIOLOGY, BIOCHEMISTRY, AND PHARMACOLOGY. 2013;31(4-5):625-637. DOI: 10.1159/000350082. SUMMARY; THE AIM WAS TO INVESTIGATE ALTERATION IN PROTEIN EXPRESSION ASSOCIATED WITH DEEP BRAIN STIMULATION (DBS) IN AN ATTEMPT TO ELUCIDATE POSSIBLE MECHANISMS OF ACTION. CEREBROSPINAL FLUID (CSF), OBTAINED FROM SIX PARKINSON¿S DISEASE (PD) PATIENTS (PRE- AND POST-DBS) AND FROM SIX NORMAL HEALTHY CONTROLS, WAS STUDIED FOR DIFFERENTIALLY EXPRESSED PROTEINS. 2-D DIGE, IN COMBINATION WITH MALDI-TOF AND TOF-TOF MASS SPECTOMETRY (MS) OR ESI-MS, WAS USED TO IDENTIFY THE CHANGED PROTEINS (3 PD PATIENTS AND 3 CONTROLS). SELECTED PROTEINS WERE FURTHER STUDIED USING WESTERN BLOTTING (6 PD PATIENTS AND 6 CONTROLS). TWENTY-ONE PROTEINS WERE IDENTIFIED AFTER MS AND PROTEIN DATABASE INTERROGATION. APART FROM APOLIPOPROTEIN A-I (APOA-I), THE EXPRESSION LEVELS OF COMPLEMENT C4, IGA TETRANECTIN AND EXTRACELLULAR SUPEROXIDE DISMUTASE (EC-SOD), DETECTED BY WESTERN BLOTTING, CORRELATED WELL WITH THE 2-D DIGE RESULTS. IN THE FOLLOW-UP PERIOD, THE EXPRESSION LEVELS OF C4, APOA-I AND IGA WERE STABLE IN ONE PATIENT DUE TO A SUICIDE ATTEMPT, THE LEVELS OF EC-SOD AND TETRANECTIN SIGNIFICANTLY DECREASED. OUR PRELIMINARY RESULTS SUGGEST THAT VARIATIONS IN THE EXPRESSION LEVELS OF EC-SOD AND TETRANECTIN IN CSF IS RELATED TO DBS. REPORTED EVENT: (B)(6) MALE PATIENT WITH PARKINSON¿S DISEASE DISCONTINUED DEEP BRAIN STIMULATION (DBS) THERAPY 8 MONTHS AFTER SURGERY DUE TO A SUICIDE ATTEMPT. THE ELECTRODES WERE NOT REMOVED DURING THE FOLLOW-UP PERIOD AND BOTH THE SUICIDAL THOUGHTS AND THE THERAPEUTIC EFFECT OF DBS DISSIPATED AFTER DISCONTINUATION OF THE DBS THERAPY. MEDICATION WAS RETURNED TO THE ORIGINAL DOSAGE. 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
    300008 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Other