BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1760748 · Received July 15, 2010

    Report

    Report Number
    3006630150-2010-01194
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WOULD UNDERGO A POCKET REVISION DUE TO THE PT'S IPG BEING TOO SHALLOW AND DIFFICULTY CHARGING. THE PHYSICIAN REPOSITIONED THE POCKET AND ADDED LEAD EXTENSIONS. THE PT WAS REPORTEDLY DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention