BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1947507 · Received December 30, 2010

    Report

    Report Number
    3007566237-2010-10882
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 15, 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). AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: MEHRKENS JH, BORGGRAEFE I, FEDDERSEN B, HEINEN F, BOTZEL K. EARLY GLOBUS PALLIDUS INTERNUS STIMULATION IN PEDIATRIC PATIENTS WITH GENERALIZED PRIMARY DYSTONIA: LONG-TERM EFFICACY AND SAFETY. J CHILD NEUROL. NOV 2010;25(11):1355-1361. SUMMARY: THE AUTHORS REPORT THE LONG-TERM FOLLOW-UP OF 5 PEDIATRIC PATIENTS UNDERGOING GLOBUS PALLIDUS INTERNUS DEEP BRAIN STIMULATION. THE THERAPY WAS REPORTED TO OFFER A VERY EFFECTIVE AND SAFE THERAPY IN PEDIATRIC PATIENTS WITH PRIMARY DYSTONIA AND THE AUTHORS INDICATE THAT EARLY NEUROSURGICAL INTERVENTION SEES TO BE CRUCIAL TO PREVENT IRREVERSIBLE IMPAIRMENT. REPORTABLE EVENT: ONE PATIENT, AN (B)(6) FEMALE, EXPERIENCED A REVISION OF THE ABDOMINAL PULSE GENERATOR POUCH TO PREVENT IMMINENT PERCUTANEOUS CABLE PERFORATION 5 MONTHS AFTER THE INITIAL IMPLANTATION.

    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 8 YR Required Intervention EXPLANTED:| LEAD: MODEL 3387, LOT# UNKNOWN| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| EXPLANTED:| LEAD: MODEL 3387, LOT# UNKNOWN| IMPLANTED:| IMPLANTED: