BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISXP - CONVENTIONAL IPG

    MDR report key: 1852345 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02715
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND 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. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. THE DEVICE WAS EXPLANTED FOR END OF LIFE (EOL). THE PATIENT USES THE MAGNET AND HARDLY EVER USES THE PROGRAMMER SO, THEY NEVER SAW THE "IPG LOW BATTERY" MESSAGE SO THE PATIENT SUDDENLY LOST STIMULATION. DOCTOR REPLACED THE CURRENT IPG WITH A SMALLER IPG AND THE PATIENT IS GETTING GOOD STIMULATION AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISXP - CONVENTIONAL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3609 34116A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other