BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1904386 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02159
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 22, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. EVAL METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: A REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT, HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. 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. REFER TO MFR REPORT # 1627487-2010-2160. THE PT RECEIVED THEIR SCS ON (B)(6) 2009. IT WAS REPORTED THAT THE PT WAS RECEIVING EFFECTIVE STIMULATION WITH THE IPG PRODUCING HIGH IMPEDANCE VALUES UNTIL AN UNK EVENT OCCURRED THAT CAUSED A LOSS OF STIMULATION AND THE PT WAS UNABLE TO OBTAIN EFFECTIVE THERAPY. IT WAS REPORTED THAT THE IPG CONTINUED TO PRODUCE HIGH IMPEDANCE VALUES AT THIS TIME. THE IPG AND EXTENSION WERE EXPLANTED ON (B)(6) 2010. THE EXPLANTED IPG WAS RETURNED TO ANS FOR EVAL. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3788 2855940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention