BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1904325 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-01652
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 3, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4). 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

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THE PATIENT'S IPG WAS TURNING OFF BY ITSELF. BOTH THE PATIENT AND THE PATIENT'S ENVIRONMENT WERE EXAMINED; HOWEVER, THE PHYSICIAN WAS NOT ABLE TO IDENTIFY ANY PHYSICAL OR ENVIRONMENTAL FACTOR(S) THAT WOULD RESULT IN THE DEVICE TURNING OFF. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2010. FOLLOW UP ON THE PATIENT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED IPG WAS RETURNED TO ANS FOR EVALUATION. NO ADDITIONAL INFORMATION WAS 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 85480

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention