BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 1842679 · Received September 3, 2010

    Report

    Report Number
    1627487-2010-02493
    Event Type
    Injury
    Date Received
    September 3, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE 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 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

    ON (B)(6)2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6)2010, THE PT WAS NOT FEELING ANY STIMULATION. THE REP AND PT TRIED TO LOCATE IPG WITH THE PROGRAMMER AND CHARGER TO NO AVAIL. THE PROGRAMMER READS IPG COMMUNICATION ERROR 2501. THE PT'S CHARGER (2ND LIGHT) FLASHED YELLOW, (3RD LIGHT) WAS FULLY GREEN. THE PT DID NOT REMEMBER WHEN THEY LAST CHARGED THE IPG. THERE WERE NO SIGNS OF ABUSE TO ANY OF THE EQUIPMENT. SJM WENT OVER THE CHARGING PROCESS SEVERAL TIMES. IT WAS VERY HARD FOR THE PT TO GRASP THE PROCESS SO, THE PT WAS PLANNING TO MEET WITH THE SJM REPS FOR "HANDS ON" INSTRUCTIONS OR MEET WITH SJM REP OR CUSTOMER SERVICE FOR TRAINING. ON (B)(6)2010, THE IPG WAS REPLACED WITH A NEW IPG SO, THE PT NO LONGER HAS TO WORRY ABOUT CHARGING ISSUES. STIMULATION WAS CAPTURED, POST-OP, AND THE PT IS HAPPY WITH THEIR STIMULATION. THE EXPLANTED IPG IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2893991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other