BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1812632 · Received August 17, 2010

    Report

    Report Number
    3006630150-2010-01414
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION DUE TO DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN RELOCATED THE IPG AND ADDED TWO LEAD EXTENSIONS. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE 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