BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052268 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-02475
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242001-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER - 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 THE PT LOST STIMULATION. HE REPORTED HE STOPPED USING THE SYSTEM SEVERAL MONTHS AGO BECAUSE HIS PAIN HAD IMPROVED; HOWEVER, HIS PAIN HAD BECOME STRONGER AND HE NEEDED TO USE THE STIMULATION AGAIN. HE STATED HIS IPG IS UNABLE TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICES AND HE CAN'T RECALL WHEN HE LAST CHARGED HIS IPG BUT THINKS IT HAS BEEN SEVERAL MONTHS. F/U IDENTIFIED THE SJM REP CONFIRMED THE DEVICE'S INABILITY TO COMMUNICATE. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139592 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2846381

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention SCS LEAD: MODEL 3214| IMPLANT DATE: