BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1940297 · Received December 17, 2010

    Report

    Report Number
    3006630150-2010-02186
    Event Type
    Injury
    Date Received
    December 17, 2010
    Report Date
    December 9, 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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT A PT'S PRECISION SYSTEM HAD BEEN EXPLANTED DUE TO AN INFECTION. NO FURTHER INFO WAS ABLE TO BE OBTAINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MODEL# SC-2218-70| (B)(4)| ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014" STYLET