BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1834125 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-01717
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    January 25, 2009
    Report Date
    March 9, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE 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. IPG AS RECEIVED PASSES THE AUTO TEST AND THE THERMAL SALINE TEST. THE IPG WAS PLACED IN A SALINE TANK AND THE TEMPERATURE CHANGES WERE MONITORED WHILE A PATIENT PROGRAM WAS RUNNING WITH AND WITHOUT CHARGING. THE TEMPERATURE VARIATIONS RECORDED ARE WITHIN SPECIFICATION. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. 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

    THE PT (COLUMBIA) RECEIVED HIS SCS SYSTEM CONSISTING OF ONE SURGICAL LEAD AND AN IPG ON (B)(6)2006. IT WAS REPORTED THE PT BEGAN EXPERIENCING AN "UNCOMFORTABLE HEATING" SENSATION WHEN RECHARGING THE IPG. THE IPG WAS EXPLANTED AND REPLACED. NO ADD'L INFO IS AVAILABLE. THE EXPLANTED IPG WAS RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 64041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention