BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1880277 · Received October 19, 2010

    Report

    Report Number
    1627487-2010-02778
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 19, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL 1 OF 3. PLEASE SEE MFG REPORT #1627487-2010-02779 FOR EVAL OF DEVICE 2 AND MFG REPORT #1627487-2010-02851 FOR EVAL OF DEVICE 3. METHOD: A VISUAL INSPECTION AND FUNCTIONAL TESTING WERE COMPLETED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE VISUAL INSPECTION REVEALED INSTRUMENT MARKS ON THE CAN, ANTENNA COVER AND HEADER. THE IPG SUCCESSFULLY COMMUNICATED WITH A PROGRAMMER AND PASSED AUTO-TESTER. THE IPG WAS PROGRAMMED USING THE PT PROGRAM PARAMETERS AND STIMULATION OUTPUT WAS MONITORED ON THE OSCILLOSCOPE WHILE CHARGING WITH NO ANOMALIES NOTED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE COMPLAINT COULD NOT BE CONFIRMED FOR "DISCOMFORT." THE IPG STIMULATION OUTPUT WAS MONITORED ON THE OSCILLOSCOPE WHILE CHARGING WITH NO ANOMALIES NOTED. 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

    DEVICE 1 OF 3. PLEASE SEE MFG REPORT #1627487-2010-02779 FOR DEVICE 2 AND MFG REPORT #1627487-2010-02851 FOR DEVICE 3. ON (B)(6) 2006, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. BEGINNING A YEAR AGO, EVERY TIME THE PT RECHARGED HER IPG, THE NEXT DAY SHE WOULD FEEL DIZZY. THE PT REPORTED THAT SHE HAD ALSO FAINTED A COUPLE TIMES. THE PT SAID SHE HAD BEEN HOSPITALIZED 6 TIMES IN THE LAST YEAR FOR DIZZINESS. THE PT DOESN'T HAVE SYMPTOMS ANY OTHER TIME, EXCEPT FOR AFTER RECHARGING, REGARDLESS OF IF SHE HAS THE STIMULATOR TURNED ON OR OFF. SHE RECHARGES WITH THE STIMULATION TURNED OFF AND DOES NOT USE THE STIMULATOR 24X7. THE STIMULATION DOES HELP HER PAIN. ON (B)(6) 2010, THE DR REPLACED THE IPG BUT THE REPLACEMENT IPG (EON MINI) DID NOT FIX THE DIZZINESS WHILE RECHARGING. THE PT'S REP HAS BEEN TOLD THAT THE ENTIRE SYSTEM WILL NOW NEED TO BE EXPLANTED BUT HE DOES NOT KNOW IF THIS EXPLANT HAS OCCURRED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 55890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other