BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON PATIENT PROGRAMMER

    MDR report key: 3082542 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-03511
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT HAS 2 SCS SYSTEMS AND RECEIVED 2 PATIENT PROGRAMMERS. THE PROGRAMMER RELATED TO THE COMPLAINT IS BEING REPORTED. IT WAS REPORTED WHEN THE - BUTTON ON THE PATIENT'S PROGRAMMER IS PRESSED THE AMPLITUDE INCREASES. THE PATIENT IS TO RECEIVE A REPLACEMENT PATIENT PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162035 EON PATIENT PROGRAMMER PATIENT PROGRAMMER LGW ST. JUDE MEDICAL - NEUROMODULATION 3851 3069695

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention IMPLANT DATE:| SCS EXTENSION, MODEL 3343 (2)| SCS EXTENSION, MODEL 3343 (2)| IMPLANT DATE:| SCS LEAD, MODEL 3169 (4)| IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE: