BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON PATIENT PROGRAMMER

    MDR report key: 2971036 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-15211
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED WHEN THE PT USES THE PLUS (+) BUTTON ON THE PT PROGRAMMER, THE BUTTON STICKS AND STIMULATION INCREASES TO THE POINT OF CAUSING DISCOMFORT. A REPLACEMENT PT PROGRAMMER WAS SENT TO THE PT. F/U IDENTIFIED THE PT RECEIVED THE NEW PROGRAMMER, AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69369 EON PATIENT PROGRAMMER SCS PATIENT PROGRAMMER LGW ST. JUDE MEDICAL - NEUROMODULATION 3851 3814118

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3228| SCS IPG: MODEL 3788| IMPLANT DATE: