BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1914966 · Received November 17, 2010

    Report

    Report Number
    3006630150-2010-01986
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    April 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT IS EXPERIENCING DIFFICULTY CHARGING EVER SINCE UNDERGOING A POCKET REVISION PROCEDURE. A BSN REP ATTEMPTED TO TROUBLESHOOT, BUT THE IPG REMAINED IN HIBERNATION. THE PT IS EXPECTED TO UNDERGO A REVISION PROCEDURE TO REPLACE THE IPG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR