BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1000428 · Received February 21, 2008

    Report

    Report Number
    2029203-2008-00061
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 22, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. 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 A PRE-EXISTING MRSA INFECTION. THE PT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS. THE PT HAS SINCE BEEN RELEASED FROM THE HOSPITAL AND THE INFECTION HAS REPORTEDLY CLEARED.

    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 YR Hospitalization| R EXPLANTED| SC-2208-50| EXPLANTED:| SC-2208-50