BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1930123 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03578
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE IPG WAS NOT RETURNED TO THE MFR FOR ANALYSIS. AS A RESULT, THE DEVICE HISTORY AND STERILIZATION RECORDS FOR THE IPG ARE CURRENTLY UNDER REVIEW. THE RESULTS OF THE REVIEW WILL BE FORWARDED WHEN AVAILABLE. SJM 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2007. IT WAS REPORTED THE IPG WILL NO LONGER ESTABLISH TELEMETRY WITH THE DEVICE CHARGER. A NEW CHARGER WAS SENT TO THE PT; HOWEVER, THE PROBLEM PERSISTED. THE PT IS CONTINUING TO WORK WITH HER PHYSICIAN ON TROUBLESHOOTING AND ANY NEXT STEPS. ACCORDING TO THE MFR'S DEVICE REGISTRATION SYSTEM, THE IPG REMAINS IMPLANTED. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL -NEUROMODULATION 3716 86909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention