BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1040520 · Received May 9, 2008

    Report

    Report Number
    2029203-2008-00293
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    February 16, 2008
    Report Date
    April 11, 2008
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG AND LEAD WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVAL. A REVIEW OF THE STERILIZATION RECORDS FOR THE EXPLANTED PRODUCTS WAS FOUND 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 ADVANCED BIONICS CORP. SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SC-8116-70| EXPLANTED