BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1800763 · Received August 12, 2010

    Report

    Report Number
    3006630150-2010-01386
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 10, 2010
    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
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS HAVING DIFFICULTY CONNECTING THE REMOTE CONTROL TO THE IPG. A FLUOROSCOPY CONFIRMED THAT THE IPG HAD NOT FLIPPED AND A MAGNET RESET WAS PERFORMED BUT WAS UNSUCCESSFUL, AN IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention