BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4112999 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-26749
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    GZB
    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 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'S IPG WAS DELETING QUICKLY. THE PT UNDERWENT SURGICAL INTERVENTION TO REMOVE AND REPLACE THE IPG AND LEADS (REFERENCE MFR. REPORT: 1627487-2014-03497). THE IPG WAS TESTED AFTER EXPLANT AND THE IPG COMMUNICATED WITH THE EXTERNAL DEVICES. IN ADDITION, WHEN THE IPG WAS EXPLANTED THE LEADS WERE COILED TIGHTLY BEHIND THE IPG AND IT APPEARED THE IPG HAD BEEN MOVING IN THE POCKET AND HAD COILED THE LEADS TIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575262 EON MINI SCS IPG GZB ST JUDE MED - NEUROMODULATION 3788 3869736

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other SCS LEAD, MODEL 3228| IMPLANT DATE: