BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3041608 · Received April 8, 2013

    Report

    Report Number
    3006630150-2013-00643
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE DUE TO HOW THE LEADS WERE ANCHORED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE TWO ANCHORS WERE REMOVED. THE PATIENT WAS DOING FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143826 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention