BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 2002333 · Received January 27, 2011

    Report

    Report Number
    1627487-2011-02098
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 3, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 REC'D A SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2008. IT WAS REPORTED THE PT CANNOT ESTABLISH TELEMETRY BETWEEN THE IPG AND THE PT PROGRAMMER. THE CHARGING SYSTEM IS ABLE TO ESTABLISH AND MAINTAIN A WEAK TELEMETRY SIGNAL. AN X-RAY WAS TAKEN AND IT APPEARS THE IPG MAY HAVE FLIPPED WITHIN THE POCKET. NONETHELESS, THE PHYSICIAN HAS REQUESTED A NEW CHARGING SYSTEM BE SENT TO THE PT TO RULE OUT ANY ISSUES WITH THE PT'S EXTERNAL DEVICES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS SINCE THE RECEIPT OF THE NEW CHARGING SYSTEM WERE UNSUCCESSFUL. ACCORDING TO THE MANUFACTURER'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 113357

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention