BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1904364 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02306
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    November 10, 2009
    Report Date
    November 11, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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. (B)(4). 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2010-02307. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PT COULD NO LONGER INCREASE THE IPG STIMULATION. BOTH THE IPG AND THE LEAD WERE EXPLANTED AND REPLACED ON (B)(6) 2009. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED. THE EXPLANTED PRODUCTS WERE NOT RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER INFO 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 115157

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention