BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4084526 · Received September 9, 2014

    Report

    Report Number
    1627487-2014-12588
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    April 5, 2014
    Report Date
    August 13, 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

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 1 OF 4. REFERENCE MFR REPORT #1627487-2014-12589. REFERENCE MFR REPORT #162487-2014-12590. REFERENCE MFR REPORT #1627487-2014-12587. IT WAS REPORTED, THE PT SCS SYS WAS REVISED ON (B)(6) 2014 (REFERENCE MFR REPORT # 1627487-2014-06021). APPROXIMATELY A MONTH LATER, THE SCS SYS WAS EXPLANTED DUE TO AN INFECTION, EXACT DATE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556410 EON MINI SCS IPG GZB ST JUDE MED - NEUROMODULATION 3788 3878223

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other