BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1882712 · Received October 13, 2010

    Report

    Report Number
    1627487-2010-02807
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. THE IPG WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE IPG WAS RETURNED WITHOUT THE PORT PLUG. INSTRUMENT MARKS WERE OBSERVED ON THE HEADER, PEEK MATERIAL AND CAN. THE IPG WAS FUNCTIONALLY TESTED AND PASSED THE AUTO TEST. CONCLUSIONS: THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, THE IPG WAS RETURNED WITHOUT A PORT PLUG. THE IPG ALSO PASSED THE AUTO TEST. 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) 2009, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, THE PT WAS SCHEDULED TO HAVE A LEAD ADDED TO HIS SYSTEM. WHEN THE DOCTOR OPENED THE POCKET, IT WAS OBSERVED THAT THE PORT PLUG WAS ABOUT 75% OUT OF THE HEADER AND BENT. THE DOCTOR FELT THAT THE IPG SHOULD BE REPLACED AND EXPLANTED THE DEVICE. POST-OPERATION THE STIMULATION WAS RECAPTURED.

    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 2835825

    Patients

    Seq Age Sex Outcome Treatment
    1 Other