BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 2002422 · Received January 28, 2011

    Report

    Report Number
    1627487-2011-02101
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 RECEIVED HER SCS SYS, INCLUDING AN IPG, ON (B)(6) 2007. IT WAS REPORTED THE IPG WILL ONLY RECHARGE TO APPROX 50 PERCENT BATTERY CAPACITY. IN ADDITION, THE PT FEELS THAT THE RECHARGE BURDEN IS TOO LONG. A NEW CHARGING SYS WAS SENT TO THE PT TO REMEDY THE ISSUE. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. ACCORDING TO THE MFR'S DEVICE REGISTRATION SYS, 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 68319

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention