BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1402516 · Received June 15, 2009

    Report

    Report Number
    2182207-2009-04143
    Event Type
    Injury
    Date Received
    June 15, 2009
    Date of Event
    April 1, 2009
    Report Date
    May 14, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: ISAIAS IU, ALTERMAN RL, TAGLIATI M. DEEP BRAIN STIMULATION FOR PRIMARY GENERALIZED DYSTONIA: LONG-TERM OUTCOMES. ARCH NEUROL. 2009; 66(4):465-470. SUMMARY: THIS REPORT DESCRIBES THE LONG-TERM CLINICAL OUTCOMES IN PATIENTS WITH PRIMARY GENERALIZED DYSTONIA (PGD) WHO UNDERWENT PALLIDAL DEEP BRAIN STIMULATION (DBS). THIRTY CONSECUTIVE PATIENTS WITH AT LEAST 2 YEARS FOLLOW-UP AFTER PALLIDAL DBS FOR INTRACTABLE PGD WERE ASSESSED. ALL PATIENTS HAD POSTOPERATIVE BRAIN MAGNETIC RESONANCE IMAGING TO CONFIRM LEAD POSITIONING WITH THE POSTEROVENTRAL SEGMENT OF THE INTERNAL GLOBUS PALLIDUS (GPI). THE STUDY WAS CONDUCTED OVER SEVERAL YEARS WITH PALLIDAL DBS AND ANNUAL FOLLOW-UP EXAMINATIONS BEING CONDUCTED UP TO 8 YEARS AFTER DBS IMPLANTATION. ALL PATIENTS EXPERIENCED SIGNIFICANT IMPROVEMENTS IN MOTOR FUNCTION. EVENT: IT WAS REPORTED THAT ONE PATIENT REQUIRED SURGICAL REPLACEMENT OF THE DEVICE DUE TO A MALFUNCTION (UNSPECIFIED).

    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 Required Intervention UNK LEAD, IMPLANT:| EXPLANT:| EXPLANT:| UNK PROGRAMMER| UNK EXTENSION, IMPLANT: