BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2132494 · Received June 17, 2011

    Report

    Report Number
    3006630150-2011-00896
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION DUE TO THE CLIK ANCHORS PROTRUDING FROM THE PATIENT'S INCISION SITE CAUSING DISCOMFORT. THE CLIK ANCHORS WERE EXPLANTED. THE PHYSICIAN BELIEVES THE DISCOMFORT WAS DEVICE RELATED AS THE CLIK ANCHORS WERE TOO BIG FOR THE THIN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4316 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention