BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1024357 · Received April 3, 2008

    Report

    Report Number
    2029203-2008-00203
    Event Type
    Injury
    Date Received
    April 3, 2008
    Date of Event
    October 4, 2007
    Report Date
    March 7, 2008
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVAL. A REVIEW OF STERILIZATION RECORDS FOR THE IPG AND LEADS FOUND THEM TO BE SATISFACTORY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE PT'S SYSTEM WAS EXPLANTED DUE TO INFECTION.

    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 Required Intervention SC-2138-50| SC-2138-50