BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI-IPG

    MDR report key: 1854289 · Received September 3, 2010

    Report

    Report Number
    1627487-2010-02492
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    June 8, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED 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) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. A REPLACEMENT CHARGER WAS SENT TO THE PT AND IT DID NOT RESOLVE THE PT'S PREVIOUS PROBLEM. THE PT HAS COMPLAINED OF A LARGE SHOCKING SENSATION 24 HOURS PREVIOUS TO THE STIMULATION TURNING OFF AND NOT BEING ABLE TO COMMUNICATE. THE PHYSICIAN PLANNED DO AN X-RAY TO SEE IF THE IPG FLIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI-IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3788 2862801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other