BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2921640 · Received January 10, 2013

    Report

    Report Number
    1627487-2013-02070
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    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

    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 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

    IT WAS REPORTED, THE PATIENT'S IPG POCKET SITE HAD OPENED UP SHOWED POSSIBLE SIGNS OF INFECTION. THE PATIENT WAS TREATED WITH PROPHYLACTIC INTRAVENOUS ANTIBIOTICS. THE PHYSICIAN TOOK THE PATIENT TO SURGERY ON (B)(6) 2012 AND NOTED THERE WERE NO SIGNS OF INFECTION IN THE POCKET BUT POCKET EROSION WAS PRESENT. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15590 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3504576

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: