BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON PT PROGRAMMER

    MDR report key: 2801314 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-02515
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 23, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODUATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    IT WAS REPORTED THE PT'S PROGRAMMER ONLY WORKS INTERMITTENTLY AND THE AMPLITUDE BUTTONS WERE STICKY. THE PT REPORTED SHE HAS SEEN VARIOUS ERROR CODES BUT SHE STILL HAD STIMULATION. A REPLACEMENT PROGRAMMER WAS SENT TO THE PT; HOWEVER, IT IS CURRENTLY UNDETERMINED WHETHER THE REPLACEMENT DEVICE RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON PT PROGRAMMER PT PROGRAMMER LGW ST. JUDE MEDICAL - NEUROMODUATION 3851 3223586

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3163| SCS IPG: MODEL 3716