BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3821281 · Received May 9, 2014

    Report

    Report Number
    1627487-2014-00279
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MED 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 MED HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S (AUSTRALIA) IPG SITE WAS NOTICEABLY SWOLLEN FOLLOWING IMPLANT. AN INFECTION AT THE IPG SITE WAS SUBSEQUENTLY CONFIRMED AND ANTIBIOTICS WERE ADMINISTERED AS TREATMENT. THIS ISSUE RESULTED IN PROLONGED HOSPITALIZATION OF THE PT. FOLLOW UP ON THIS MATTER FOUND THE INFECTION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282137 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4237403

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization SCS LEADS: MODEL 3156 (2)| IMPLANT DATE:| SCS LEADS: MODEL 3186| IMPLANT DATE: