BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790691 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01616
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    March 14, 2008
    Report Date
    May 28, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. AS RECEIVED, THE TOP SETSCREW WAS OUT OF THE BLOCK CONNECTOR AND UNDER THE SEPTUM. IPG PASSED ALL TESTING INCLUDING LEAD RETENTION TESTING. 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 PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF AN IPG AND 2 PERCUTANEOUS LEADS ON (B)(6) 2008. IT WAS REPORTED THAT AFTER IMPLANT, ONE OF THE ELECTRODES MEASURED INVALID. AN X-RAY SHOWED THAT ONE OF THE LEADS HAD PULLED OUT OF THE IPG HEADER. THE PHYSICIAN ATTEMPTED TO REINSERT THE LEAD IN THE HEADER ON (B)(6) 2008 BUT AFTER REINSERTING THE LEAD INTO THE HEADER, THE SET SCREW WAS UNSEATED AND IT WOULD NOT CLICK WHEN TIGHTENED DOWN AND THE LEAD COULD EASILY BE PULLED BACK OUT. THE IPG WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL. THE PATIENT'S EXISTING LEADS WERE REUSED. THE EXPLANTED IPG WAS RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    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 114165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention