BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2000663 · Received February 16, 2011

    Report

    Report Number
    3006630150-2011-00215
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN INSPECTED THE IPG AND FOUND NO ISSUES. THE PHYSICIAN WILL NOT TAKE ANY FURTHER ACTION AT THIS TIME. THE PATIENT WAS RECEIVING STIMULATION AND WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT FELT HER IPG WAS FLIPPING AROUND IN THE POCKET. THE PHYSICIAN ASSESSED THE POCKET AND ALTHOUGH EVERYTHING LOOKED FINE, HE AGREED TO REVISE THE PATIENT'S POCKET SITE IF THE PT WANTED TO.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT FELT HER IPG WAS FLIPPING AROUND IN THE POCKET. THE PHYSICIAN ASSESSED THE POCKET AND ALTHOUGH EVERYTHING LOOKED FINE, HE AGREED TO REVISE THE PATIENTS POCKET SITE IF THE PATIENT WANTED TO.

    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 51 YR Required Intervention