BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3180815 · Received June 20, 2013

    Report

    Report Number
    3006630150-2013-01278
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD PAIN AT THE POCKET SITE. THE PHYSICIAN IDENTIFIED IT AS A MECHANICAL PROBLEM THAT CAUSED IRRITATION AT THE SITE WHERE THE IPG WAS ORIGINALLY IMPLANTED. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN, THE PHYSICIAN RELOCATED THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281200 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention