BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1936054 · Received December 10, 2010

    Report

    Report Number
    3006630150-2010-02033
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTENSIONS WERE EXPLANTED ON (B)(6) 2010.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WILL UNDERGO A POCKET AND LEAD EXTENSION REVISION DUE TO DISCOMFORT. THE PHYSICIAN REPOSITIONED THE PT'S IPG AND REPLACED THE EXTENSIONS. THE PT IS 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 SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention (B)(4)| SCS PHIII ETX, 55 CM:| (B)(4)| MODEL#: SC-3138-55