BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2980296 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-15251
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 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 2. REFERENCE MFR. REPORT: 1627487-2013-15252. IT WAS REPORTED THE PATIENT HAD AN INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND PLACED ON ANTIBIOTICS AND PAIN MEDICINE. THE PATIENT'S SCS SYSTEM WAS EXPLANTED. NO INFORMATION IS AVAILABLE AS TO THE TYPE OF INFECTION. FOLLOW-UP INDICATED THE PATIENT IS IN PAIN BUT DOING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77649 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3856730

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R