BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2932153 · Received January 25, 2013

    Report

    Report Number
    1627487-2013-04123
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    September 18, 2012
    Report Date
    January 4, 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 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

    DEVICE 2 OF 2. REF MFR REPORT #: 1627487-2013-04089. THE PT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS UNABLE TO ADJUST THE AMPLITUDE OF THE STIMULATION DUE TO AUTO-REDUCTION OF THE SYSTEM. THE PT REPORTED SHE HAD FALLEN PRIOR TO ISSUE OCCURRING. THE SJM REP MET WITH THE PT FOR REPROGRAMMING AND DETERMINED THERE WERE MULTIPLE CONTACTS WITH INVALID IMPEDANCES. AT THE REPROGRAMMING SESSION THE PT RECEIVED A SHOCKING SENSATION AT THE IPG SITE, BUT IT WAS REPORTED THIS WAS RESOLVED. THE DEVICE MFR'S SYSTEM SHOWED THE IPG AND LEADS WERE REPLACED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36329 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3552198

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention