BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SPINAL CORD STIMULATOR

    MDR report key: 1517072 · Received October 20, 2009

    Report

    Report Number
    2182207-2009-07582
    Event Type
    Malfunction
    Date Received
    October 20, 2009
    Date of Event
    February 14, 2009
    Report Date
    March 11, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL ASSESSMENT.

    Description of Event or Problem · 1

    LITERATURE: VRBA I, KOZAK J, KORAN M, KNOTEK P, STETKAROVA I. [BIO-PSYCHO-SOCIAL ASSESSMENT OF NEUROMODULATION ANALGESIC TREATMENT OF PTS WITH FAILED BACK SURGERY SYNDROME (FIRST PART)]. BOLEST. 2008; 11(4): 207-214. SUMMARY: THIS ARTICLE PRESENTS THE USE OF NEUROMODULATION ANALGESIC METHODS (BOTH STIMULATION AND DRUG DELIVERY) FOR THE TREATMENT OF FAILED BACK SURGERY SYNDROME (FBSS) IN 36 PTS, WHO FAILED CONVENTIONAL MEDICATION MANAGEMENT AND SUCCESSFULLY FULFILLED THE TRIAL PERIOD. TWENTY-FOUR PTS WERE IMPLANTED WITH NEUROSTIMULATION SYSTEMS WITH ONE ELECTRODE, 2 PTS WERE IMPLANTED WITH NEUROSTIMULATION SYSTEMS WITH TWO ELECTRODES, AND 12 PTS WERE IMPLANTED WITH A PUMP SYSTEM. REPORTABLE EVENT: FIVE PTS EXPERIENCED A CHANGE IN ELECTRODE POSITION/MIGRATION WITH LOSS OF ANALGESIC PARESTHESIA IN THE RELEVANT PAINFUL AREAS. THE PT WAS REPROGRAMMED AND THIS RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION UNK NA

    Patients

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