BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052387 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-13505
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 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 TOT HIS 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: 1627487-2013-13506. IT WAS REPORTED THE PATIENT HAD AN INFECTION AT HER IPG POCKET SITE. THE PATIENT'S ENTIRE SCS SYSTEM WAS EXPLANTED. FOLLOW-UP INFORMATION IDENTIFIED THE PATIENT HAD CALLER HER PHYSICIAN ON (B)(6) 2013 AND WAS COMPLAINING OF A FEVER AND CONTINUING SYMPTOMS AT THE IPG INCISION SITE. THE PATIENT WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM. ADDITIONAL FOLLOW-UP IDENTIFIED THE PATIENT WAS SEEN BY HER PHYSICIAN ON (B)(6) 2013 AND HER INFECTION HAD COMPLETELY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135542 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3876660

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention