BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790820 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01680
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. IPG FAILS THE AUTO TEST FOR IMPEDANCE, GAIN, AND OFFSET. GAIN AND OFFSET ARE USED FOR IMPEDANCE MEASUREMENTS ONLY AND DO NOT AFFECT STIMULATION PERFORMANCE OR THE SYMPTOM AS DESCRIBED FOR RANDOM POWERING OFF AND ON. IPG WAS REPROGRAMMED WITH PATIENTS SETTINGS AS RECEIVED IN ANS-LAB AND PER THE SETTINGS INDICATED IN THE COMPLAINT AS OF (B)(6) 2008 THEN WAS MONITORED FOR OUTPUTS SHUTTING OFF. IT IS UNKNOWN WHAT CAUSED THE GAIN AND OFFSET VALUES TO BE ZEROED. 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 AN SCS SYSTEM CONSISTING OF TWO PERCUTANEOUS LEADS AND AN IPG ON (B)(6) 2006. IT WAS REPORTED THAT EVALUATION OF THE PATIENT'S IPG REVEALED UNACCEPTABLE IMPEDANCES (0 OHMS). THE PATIENT REPORTED THE DEVICE WOULD SHUT OFF AFTER AN HOUR OF USE; TURNING BACK ON LATER SPONTANEOUSLY. ADDITIONAL REPROGRAMMING ATTEMPTS DID NOT RESOLVE THE REPORTED PROBLEM. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B)(6) 2008. THE EXPLANTED IPG WAS RETURNED TO (B)(4) FOR EVALUATION. NO FURTHER INFORMATION 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 47591

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention