BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1885229 · Received October 25, 2010

    Report

    Report Number
    3007566237-2010-08435
    Event Type
    Death
    Date Received
    October 25, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PT. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PTS. AT THIS TIME, NO ADD'L INFO WAS AVAILABLE, ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: BURDICK AP, FERNANDEZ HH, OKUN MS, CHI YY, JACOBSON C, FOOTE KD. RELATIONSHIP BETWEEN HIGHER RATES OF ADVERSE EVENTS IN DEEP BRAIN STIMULATION USING STANDARDIZED PROSPECTIVE RECORDING AND PT OUTCOMES. NEUROSURG FOCUS. AUG 2010;29(2):E4. SUMMARY: THE AUTHORS DISCLOSE THE STANDARDIZED AND PROSPECTIVELY RECORDED AE DATA FROM THEIR INSTITUTION BETWEEN (B)(6) 2002 AND (B)(6) 2008. TWO HUNDRED SEVENTY DBS PROCEDURES WERE PERFORMED IN 198 PTS; 26 PTS HAD DYSTONIA, 43 HAD ESSENTIAL TREMOR, 113 HAD PARKINSON DISEASE, 6 HAD OCD, AND 10 HAD OTHER CAUSES OF TREMOR. THE DBS LEADS WERE IMPLANTED ON THE LEFT HEMISPHERE IN 133 PROCEDURES, ON THE RIGHT IN 88, AND BILATERALLY IN 49. A TOTAL OF 300 AES WERE RECORDED IN 146 OF THE 270 PROCEDURES, AND THE AES WERE RECORDED IN 119 OF 198 PTS. NO SIGNIFICANT QOL DIFFERENCES. EVENT: THE FREQUENCY OF THE 300 ADVERSE EVENTS WERE AS FOLLOWS: MENTAL STATUS DECLINE 53, OTHER (UNSPECIFIED) 43, GAIT PROBLEM 21, OTHER MOTOR PROBLEM 20, SEIZURE 16, ICH (SYMPTOMATIC) 16, LEAD MISPLACEMENT 15, SPEECH-APHASIA 13, SPEECH-DYSARTHRIA 11, SUBDURAL/OTHER BLEED 11, MANIA/HYPOMANIA 8, INFECTION, DEEP (HARDWARE REMOVAL) 7, AIR EMBOLUS 6, SPEECH-HYPOPHONIA 6, DEPRESSION 6, INFECTION, DEEP (REVISION, IV ANTIBIOTICS) 5, SWALLOW PROBLEM 5, ANXIETY 5, INCONTINENCE 4, VISUAL PROBLEM 4, INFECTION, SUPERFICIAL (ORAL ANTIBIOTICS) 4, HARDWARE MALFUNCTION (OTHER) 4, DEATH 2, HARDWARE MALFUNCTION (FRACTURE) 2, HYDROCEPHALUS 2, NEUROLOGICAL DEFICIT (OTHER) 2, STROKE 2, SCALP EROSION 2, SUICIDAL IDEATION 2, IPG SEROMA 1, OTHER SENSORY PROBLEM 1 AND PSYCHOGENIC DISORDER 1. SEE ATTACHED LITERATURE ARTICLE.

    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 57 YR Death| R UNK LEADS| UNK EXTENSIONS| UNK PROGRAMMERS