BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1904297 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02092
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    May 2, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 2. EVALUATION: METHOD - 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. 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2010-02091. THE PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF TWO LEADS AND AN IPG ON AN UNKNOWN DATE. THE LEADS WERE IMPLANTED IN THE OCCIPITAL AREA (OFF-LABEL PLACEMENT). IT WAS REPORTED THAT THE PATIENT STATED THE SYSTEM NEVER WORKED FOR HER AND SHE REQUESTED THE SYSTEM BE EXPLANTED. THE SYSTEM WAS EXPLANTED ON (B)(6) 2008. THE EXPLANTED DEVICES WERE RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 67526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention