BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3001444 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-12308
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 RELATED TO THIS EVENT 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 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 6. REFERENCE MFR REPORT #1627487-2013-12309, 12310, 12311, 12312 AND 12313. IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR PNS LEAD REVISION (OFF-LABEL USE). DURING THE PRE-OP ASSESSMENT THE PATIENT HAD A FEVER, NAUSEA AND CHILLS. THE PHYSICIAN SUSPECTED INFECTION AND EXPLANTED THE ENTIRE SYSTEM. NOTE THE PATIENT RECEIVED FOUR LEADS FROM THREE DIFFERENT LOT NUMBERS. THE PATIENT ALSO RECEIVED TWO EXTENSIONS FROM TWO DIFFERENT LOT NUMBERS. ALL DEVICES ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94152 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3857068

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention