BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1943753 · Received December 21, 2010

    Report

    Report Number
    3006630150-2010-02200
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT DURING A LEAD REVISION SURGERY (DUE TO INADEQUATE COVERAGE), A PT'S PRECISION SYSTEM WAS EXPLANTED. THE PHYSICIAN NOTICED THAT THE PT'S IPG WAS ERODING THROUGH THE SKIN. NO INFECTION WAS SUSPECTED AND THE PT IS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    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 49 YR Required Intervention LEAD EXTENSION, 25 CM| MODEL# SC-2218-50, (B)(4)| MODEL# SC-3138-25, (B)(4)| (B)(4)| (B)(4)| ST LINEAR LEAD, 50 CM W/ PRE-LOADED 0.014" STYLET