BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4091919 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-23561
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 6, 2013
    Report Date
    August 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBERS: 1627487-07262012-002-R. 1627487-12192011-003-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'S IPG IS INOPERABLE. IT WAS ALSO REPORTED THE PT HAS NOT USED HIS SCS SYSTEM IN APPROXIMATELY A YEAR, AS HE HAS NOT BEEN IN MUCH PAIN. SUBSEQUENTLY, THE PT IS REQUESTING TO HAVE HIS SCS SYSTEM REMOVED. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526424 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2847287

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3219