BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4212820 · Received October 24, 2014

    Report

    Report Number
    1627487-2014-06302
    Event Type
    Injury
    Date Received
    October 24, 2014
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-06301. THE PT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION AND STOPPED USING AND CHARGING HER SCS SYS SIX MONTHS AFTER IMPLANT. IN ADDITION THE PT NEEDS AN MRI (FOR UNRELATED ISSUE) AND IS REQUESTING TO HAVE HER SCS SYS REMOVED. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678923 EON SCS IPG GZB ST JUDE MED - NEUROMODULATION 3716 68514

    Patients

    Seq Age Sex Outcome Treatment
    1