BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3043357 · Received April 9, 2013

    Report

    Report Number
    3006630150-2013-00653
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE IPG WAS PROTRUDING AND THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN CONFIRMED THAT THERE WAS NO ACTUAL BREAK IN THE SKIN. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE IPG WAS MOVED DEEPER. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145662 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention