BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1790703 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01642
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    August 28, 2009
    Report Date
    August 28, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE IPG WAS NOT COMFORTABLE FOR THE PT AND THAT IT WAS NOT WORKING PROPERLY. THE IPG WAS REPLACED ON (B)(6) 2009 WITH A SMALLER MODEL IPG. FOLLOW UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED IPG WAS RETURNED TO ANS FOR EVALUATION. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 115159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention