BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1220492 · Received November 4, 2008

    Report

    Report Number
    2029203-2008-00887
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    January 1, 2005
    Report Date
    October 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
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR EVAL AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT A PT'S PRECISION SYSTEM WAS EXPLANTED, DUE TO INFECTION. THE PT WAS GIVEN GENTAMICIN IV AS ANTIBIOTIC FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-1100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MODEL SC-2108-70M| LINEAR LEAD