BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1812631 · Received August 17, 2010

    Report

    Report Number
    3006630150-2010-01426
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 26, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING TROUBLE CHARGING HER DEVICE. THE IPG WAS IMPLANTED IN THE PATIENT'S STOMACH AND AFTER WEIGHT GAIN IT HAD BECOME DIFFICULT FOR THE PATIENT TO CHARGE. THE PHYSICIAN HAS RECOMMENDED A POCKET REVISION.

    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