BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1872768 · Received October 14, 2010

    Report

    Report Number
    3007566237-2010-07967
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    July 8, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IT IS ALSO POSSIBLE, SEVERAL EVENTS OCCURRED IN ONE PATIENT. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: GRUBER D, KUHN AA, SHOENECKER T, ET AL. PALLIDAL AND THALAMIC DEEP BRAIN STIMULATION IN MYOCLONUS-DYSTONIA. MOV DISORD. AUG 15 2010; 25(11):1733-1743. SUMMARY: THE AUTHORS INVESTIGATED SHORT- AND LONG TERM EFFECTS ON MOTOR FUNCTION, COGNITION, AFFECTIVE STATE, AND QUALITY OF LIFE (QOL) OF GPI- AND VIM-DBS IN MYOCLONUS-DYSTONIA (MD). TEN MD PATIENTS WERE EVALUATED PRE- AND POST-SURGERY BETWEEN 1997 AND 2009. BOTH GPI- AND VIM-DBS ARE EFFECTIVE. THERE WERE FEWER ADVERSE, STIMULATION INDUCED EVENTS WITH GPI-DBS IN COMPARISON WITH VIM-DBS. THERE WERE 18 REVERSIBLE STIMULATION-DEPENDENT ADVERSE EVENTS (AE) IN THE VIM GROUP WHICH RESOLVED BY ADAPTATION OF PARAMETERS; THESE INCLUDE DYSARTHRIA, DYSPHAGIA, DYSGEUSIA, WORSENING DYSTONIA, HEADACHE, GAIT DISTURBANCE, DYSAESTHESIAS. THERE WERE 4 EVENTS EXPERIENCED BY THE GPI GROUP; THESE WERE NAUSEA AND PHOSPHENE. IT WAS UNCLEAR WHICH PATIENTS EXPERIENCED WHICH ADVERSE EVENT; HOWEVER, NO SERIOUS LONG-LASTING STIMULATION-RELATED AE'S WERE OBSERVED. REPORTABLE EVENT: PATIENT 1 OF 10 RECEIVED BILATERAL VIM-ELECTRODES; THIS PATIENT EXPERIENCED AN INFECTION OF THE IPG EIGHT YEARS POST SURGERY AND REQUIRED AN EXPLANTATION. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED FOR THE DIFFERENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention UNKNOWN CONVERSTION TYPE: MODEL LEADN, LOT# UNK| PROGRAMMER: MODEL PROGRAMMER, LOT# UNKNOWN| UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: