BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1163593 · Received September 17, 2008

    Report

    Report Number
    2029203-2008-00668
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED THAT A PT'S IPG POCKET WAS LOOSE AND THE IPG WAS MOVING AROUND. THE SURGEON DECIDED TO REVISE THE POCKET AND ADJUST THE IPG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention