BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESIS XP 8-CHANNEL IPG

    MDR report key: 978061 · Received January 10, 2008

    Report

    Report Number
    1627487-2007-00037
    Event Type
    Other
    Date Received
    January 10, 2008
    Date of Event
    December 6, 2007
    Report Date
    January 10, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS INC
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSIONS: DEVICE WAS RETURNED FOR EVAL WHICH IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE. ANS INC CORP HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS INC CORP DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN IPG IN 2004. APPROXIMATELY, 2 MONTHS LATER, THE PT REPORTED SKIN EROSION NEAR THE EXTENSION CONNECTOR AREA. THE PT WENT TO THE ER AND HER SYS WAS EXPLANTED. FOLLOW-UP ON THE PT FOUND THAT CULTURES TAKEN FROM THE WOUND SITE TESTED NEGATIVE FOR INFECTION. THE PT IS SCHEDULED TO RECEIVE A NEW SYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS XP 8-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS INC 3609 27236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other