BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1871072 · Received October 12, 2010

    Report

    Report Number
    3006630150-2010-01767
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVAL AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER THE PT WAS IMPLANTED WITH TRIAL LEADS, IN RECOVERY, THE PT EXPERIENCED SEVERE NEUROPATHIC PAIN IN HER RIGHT LEG. THE PAIN DID NOT SETTLE WITH ADMINISTRATION OF ANALGESIA. REPROGRAMMING WAS NOT SUCCESSFUL IN RELIEVING PT'S PAIN. THE PHYSICIAN BELIEVES THE INSERTION OF THE LEAD CAUSED TEMPORARY INFLAMMATORY REACTION. THE PT WAS ADMITTED TO THE HOSPITAL AND PLACED ON KETAMINE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R ST LINEAR TRIAL LEAD, 50CM WITH| MODEL #: SC-2218-50-E, SERIAL #: (B)(4)| PRE-LOADED 0.014" STYLET (STREAMLINED)