BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1343103 · Received March 12, 2009

    Report

    Report Number
    2029203-2009-00318
    Event Type
    Injury
    Date Received
    March 12, 2009
    Date of Event
    January 12, 2009
    Report Date
    January 12, 2009
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT OF THE PT GETTING A POCKET REVISION DUE TO NOT BEING ABLE TO RECEIVE AN OPTIMAL CHARGE. THE PT IS ABLE TO CHARGE AFTER THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention