BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3801070 · Received May 8, 2014

    Report

    Report Number
    3006630150-2014-01024
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DISCOMFORT AT THE POCKET SITE DUE TO THE POSITION OF THE IPG. THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS REPLACED PER PREFERENCE AND WAS RELOCATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277645 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention