BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1885167 · Received October 25, 2010

    Report

    Report Number
    3006630150-2010-01820
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT UNDERWENT A POCKET REVISION DUE TO DIFFICULTY CHARGING HER IPG. IT WAS DETERMINED THAT THE IPG WAS TOO DEEP. THE PHYSICIAN RELOCATED THE POCKET AND THE PT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention