BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS XP IPG

    MDR report key: 1904124 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02361
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT (SWEDEN) REC'D THEIR SCS SYSTEM ON (B)(6) 2005. IT WAS REPORTED THAT THERE WAS A HEATING SENSATION AROUND THE IPG SITE, AND IT APPEARED RED AND SWOLLEN. THE IPG WAS REPLACED ON (B)(6) 2008. THE EXPLANTED IPG WAS RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS XP IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3644 37682B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention