BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1972398 · Received January 20, 2011

    Report

    Report Number
    3007566237-2011-00490
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 3, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PT. AT THIS TIME, NO ADD'L INFO WAS AVAILABLE, ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: DEMARTINI L, STOCCO E, BONEZZI C. FAILED BACK SURGERY SYNDROME AND INTRATHECAL DRUGS INFUSION. EUROPEAN JOURNAL OF PAIN SUPPLEMENTS 2010; 4(4): 299-301. SUMMARY: THE AUTHORS WERE INTERESTED IN SUBJECTS WITH FAILED BACK SURGERY SYNDROME (FBSS) THAT UNDERWENT A TRIAL FOR INTRATHECAL DRUG INFUSION; THEY FOCUSED ON THE DRUGS USED, OUTCOMES AND SIDE EFFECTS. FIFTY-SIX PTS WERE TREATED WITH INTRATHECAL DRUGS FOR NON-CANCER PAIN OVER A 14 YEAR PERIOD; TWENTY OF THESE PTS HAD FBSS. DRUGS USED INCLUDED MORPHINE, HYDROMORPHONE, ZICONOTIDE, BUPIVICAINE AND CLONIDINE. REPORTABLE EVENT: THE AUTHORS REPORTED TWO CASES OF MENINGITIS THAT WAS EXPERIENCED DURING THE TRIAL PHASE DUE TO MALPRACTICE; THIS WAS CURED WITH SYSTEMIC ANTIBIOTICS. THE AUTHORS REPORTED THAT THIS NO LONGER OCCURS SINCE PORTS WITH MICROFILTERS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN LKK MEDTRONIC NEUROMODULATION CATHETER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED: