BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1940346 · Received December 20, 2010

    Report

    Report Number
    3006630150-2010-02131
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    September 15, 2010
    Report Date
    November 29, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEIR LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT TRIAL PATIENT WAS EXPLANTED DUE TO AN EPIDURAL ABSCESS. THE PHYSICIAN TREATED THE PATIENT AND THE PATIENT IS HEALING PROPERLY AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R (B)(4)| ENH ST LD KIT, 70CM, MODEL # SC-2218-70T