BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1566589 · Received December 17, 2009

    Report

    Report Number
    3007566237-2009-09412
    Event Type
    Malfunction
    Date Received
    December 17, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 8, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    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 PT'S IMPLANTED WITH DEEP BRAIN STIMULATION (DBS) BETWEEN 1997 TO THE END OF 2008 AT ONE FACILITY TO ASSESS COMPLICATIONS ARISING FROM THE 100 DBS ELECTRODE INSERTIONS AND PREVENTION OF COMPLICATIONS. REPORTABLE EVENT: ONE PT EXPERIENCED ELECTRODE FRACTURE AT THE DISTAL END, CLOSE TO THE CONNECTOR SITE. IT WAS NOTED THAT THE CONNECTOR WAS NOT ANCHORED PROPERLY AND WAS MIGRATING FROM THE RETROAURICULAR REGION DOWN TO THE NECK LEVEL. THE PULLING AND DRAGGING FORCE FRACTURED THE ELECTRODE. NO PT SYMPTOMS, TREATMENT, OR OUTCOME WERE REPORTED. SEE LITERATURE ARTICLE WITH MFR REPORT #3007566237-2009-09382.

    Devices

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

    Patients

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