BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1250416 · Received December 3, 2008

    Report

    Report Number
    2029203-2008-00982
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE PT HAD A POCKET REVISION DUE TO DISCOMFORT AT THE POCKET SITE. DURING THE REVISION, IT WAS DISCOVERED THAT THE PT HAD SEROMA AT THE POCKET SITE. THE SITE WAS DRAINED AND SUTURED BACK UP. THE PT HAD NO SIGNS OF INFECTION AND IS REPORTEDLY DOING WELL.

    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 52 YR Required Intervention