BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1566213 · Received December 16, 2009

    Report

    Report Number
    3007566237-2009-09384
    Event Type
    Injury
    Date Received
    December 16, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 8, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: CHAN DTM, ZHU XL, YEUNG JHM, ET AL. COMPLICATIONS OF DEEP BRAIN STIMULATION: A COLLECTIVE REVIEW. ASIAN J SURG. 2009; 32(4): 258-63. SUMMARY: THIS ARTICLE PRESENTS AN AUDIT OF ALL THE PATIENTS IMPLANTED WITH DEEP BRAIN STIMULATION (DBS) BETWEEN 1997 TO 2008 AT ONE FACILITY TO ASSESS COMPLICATIONS ARISING FROM THE 100 DBS ELECTRODE INSERTIONS AND PREVENTION OF COMPLICATIONS. REPORTABLE EVENT: TWO PATIENTS EXPERIENCED ELECTRODE MALPOSITION. BOTH PATIENTS SUFFERED INTOLERABLE STIMULATION SIDE EFFECTS AND UNDERWENT REVISION. NO PATIENT OUTCOME WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| IMPLANETD:| EXPLANTED:| EXTENSION: MODEL UNKNOWN, LOT# UNKNOWN| LEAD: MODEL UNKNOWN, LOT# UNKNOWN