BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4240526 · Received October 30, 2014

    Report

    Report Number
    1627487-2014-26918
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4). 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 #1 OF 2: REFERENCE MFR. REPORT: 1627487-2014-26919. IT WAS REPORTED THE PATIENT DID NOT RECEIVE EFFECTIVE STIMULATION. THE PATIENT REPORTS SHE COULD NOT KEEP THE STIMULATION TURNED UP HIGH ENOUGH TO PROVIDE EFFECTIVE STIMULATION. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE THE IPG, HOWEVER, THE LEAD WAS NOT REMOVED BECAUSE THE PATIENT DID NOT WANT TO UNDERGO A MAJOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696632 EON MINI SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3788 3792813

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS ANCHOR: MODEL 1194(2)| IMPLANT DATE: