BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2823318 · Received November 7, 2012

    Report

    Report Number
    3006630150-2012-02036
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL:SC-2218-50, SERIAL: (B)(4), DESCRIPTION:LINEAR ST LEAD WITH PRELOADED ENHANCED STYLET-50CM. EXPLANTED IPG AND LEADS WILL NOT BE RETURNED TO BSN AS THEY WERE DISCARDED BY MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING POCKET DISCOMFORT. THE PATIENT UNDERWENT A POCKET REPOSITIONING PROCEDURE AND THE PHYSICIAN CHOSE TO REPLACE THE IPG DUE TO PHYSICIAN'S PREFERENCE. THE PHYSICIAN CHOSE TO REPLACE THE PERCUTANEOUS LEADS AND IMPLANT AN INFINION LEAD IN AN ATTEMPT TO ACHIEVE BETTER COVERAGE FOR THE PATIENT. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING 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 74 YR Required Intervention