BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1881451 · Received October 8, 2010

    Report

    Report Number
    1627487-2010-02790
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND 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. 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

    ON (B)(6) 2009, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. IT WAS REPORTED THAT THE PT HAS NOT RECHARGED THE DEVICE FOR SIX MONTHS AND IS WITHOUT STIMULATION. THE PROGRAMMER AND CHARGER NO LONGER COMMUNICATE WITH THE IPG. THE PT WAS SENT A REPLACEMENT CHARGER. ON (B)(6) 2010, IT WAS REPORTED THAT THE REPLACEMENT CHARGER DID NOT RESOLVE THE ISSUE. THE DOCTOR BELIEVES THAT THE IPG BATTERY IS DEPLETED AND PLANS TO REPLACE THE DEVICE WITH A NON RECHARGEABLE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2812445

    Patients

    Seq Age Sex Outcome Treatment
    1 Other