BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790802 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01618
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    June 10, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 5. 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 RETURNED WAS VISIBLY DAMAGED. INITIAL TESTING ¿ THE IPG COMMUNICATED BUT FAILED THE AUTO TEST. AT FINAL ANALYSIS THE IPG FAILED TO COMMUNICATE AND APPEARED NONFUNCTIONAL. IT WAS DISCOVERED THAT A PCB COMPONENT WAS DEFECTIVE. ONCE REPLACED, THE IPG FUNCTIONED PROPERLY. 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

    DEVICE 1 OF 5. REFERENCE MANUFACTURER¿S REPORTS: 1627487-2010-01619; 1627487-2010-01620; 1627487-2010-01627 AND 1627487-2010-01628. THE PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF AN IPG, 2 PADDLE LEADS AND 2 EXTENSIONS ON (B)(6) 2006. IT WAS REPORTED THAT THE SYSTEM CEASED TO FUNCTION. AFTER TESTING THE EXTENSIONS AND LEADS AND RECEIVING ALL INVALID CONTACTS, THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH A NEW SYSTEM. THE EXPLANTED IPG, LEADS, AND EXTENSIONS WERE RETURNED TO ANS FOR ANALYSIS. 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 49139

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention