BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 2002334 · Received January 27, 2011

    Report

    Report Number
    1627487-2011-02103
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 AN SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2009. IT WAS REPORTED THE IPG HAS NO OUTPUT AND NO TELEMETRY. ACCORDING TO THE PT, STIMULATION WAS LOST APPROXIMATELY THREE MONTHS PRIOR. AS A RESULT, THE PT DID NOT ATTEMPT TO RECHARGE THE IPG. AN IPG REVISION WAS RECOMMENDED BY THE PHYSICIAN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS 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 MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL- NEUROMODULATION 3788 2788115

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention