BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110729 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-03623
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 PATIENT REPORTED, SHE IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER SCS IPG AND PATIENT PROGRAMMER WHICH DISPLAYS A COMM ERROR 2501 MESSAGE. THE PATIENT TRIED TROUBLESHOOTING TO NO AVAIL AND IS NO LONGER RECEIVING STIMULATION, SUBSEQUENTLY, A REPLACEMENT PROGRAMMER WAND WAS SENT TO THE PATIENT, FOLLOW-UP IDENTIFIED THE WAND DID NOT RESOLVE THE ISSUE. ADDITIONALLY, A SJM REP CONFIRMED THE ISSUE AND WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN THE SCS IPG AND MULTIPLE EXTERNAL DEVICES. IT WAS ALSO REPORTED, THE PATIENT WAS EXPERIENCING INTERMITTENT COMMUNICATION BETWEEN THE CHARGING SYSTEM AND SCS IPG BEFORE COMMUNICATION WAS LOST. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202726 EON MINI SCS IPG LGW ST. JUDE MEDICAL- NEUROMODULATION 3788 3486476

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT DATE,| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)