BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1852359 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02782
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    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 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 2 OF 2. PLEASE SEE MFR REPORT #1627487-2010-02580 FOR DEVICE 1. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. AFTER THE IMPLANT, THE PT WAS MOVED TO THE RECOVERY ROOM AND COULD INITIALLY MOVE AND FEEL HIS LEGS AND FEET. ABOUT 20 MINS INTO RECOVERY, THE PT LOST FEELING IN BOTH LEGS AND FEET. THE IPG AND LEAD WERE REMOVED AND THE PT WAS TRANSFERRED TO THE HOSPITAL FOR OVERNIGHT OBSERVATION. THE FOLLOWING DAY, THE PT REGAINED ALL FEELING AND MOVEMENT IN BOTH LEGS AND FEET AND WAS BEING DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2010 THE DOCTOR TOLD THE CLINICAL SPECIALIST THAT THE PT HAD DEVELOPED A SMALL HEMATOMA, WHICH WAS SUBSEQUENTLY REMOVED. ON (B)(6) 2010, THE PT WAS REIMPLANTED AND THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 3126728

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization