BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3110748 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-08058
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    ---
    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

    RESULTS: COMPLAIN WAS CONFIRMED. THE PT DID NOT RECHARGE FOR SEVERAL MONTHS. ACCORDING TO THE EON DFU REVIEW, IF THE DEPLETED IPG WAS NOT CHARGED WITHIN 2-18 MONTHS THE IPG MAY LOSE ITS ABILITY TO BE RECHARGED. THEREFORE, THE REPORTED COMPLAINT IS CONFIRMED AND IS CONSIDERED TO BE A USER ERROR. 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

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-08057. THE PT RECEIVED TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS HAVING INADEQUATE STIMULATION DUE TO LEAD MIGRATION AND THE PHYSICIAN SUSPECTED THE LEADS WERE NOT IN THE EPIDURAL SPACE. ALTHOUGH THE PT WAS HAVING EFFECTIVE STIMULATION INITIALLY, THE PT STOPPED CHARGING THE IPG (IMPLANTABLE PULSE GENERATOR) DUE TO INEFFECTIVE PAIN RELIEF. THE PT HAD A DEVICE EXPLANT AND THE PHYSICIAN HAD PLANNED TO DO A TRIAL PROCEDURE AT A FUTURE DATE TO ADDRESS THE CHANGED PAIN PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204783 EON SCS IPG --- ST. JUDE MEDICAL - NEUROMODULATION 3716 66916

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention