BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 1892673 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-03115
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION WAS NOT PERFORMED AS THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED BY PRODUCT TESTING. 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 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 3 (SEE MFR REPORT #S 1627487-2010-03116 AND 1627487-2010-03117 FOR DEVICES 2 AND 3.) THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG, TWO LEADS AND TWO ANCHORS. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG POCKET AND LEAD INCISION SITES. AT THE TIME OF THE REPORT, CULTURES HAD NOT BEEN TAKEN; HOWEVER, THE PATIENT WAS BEING TREATED WITH INTRAVENOUS ANTIBIOTICS. THE PATIENT'S SCS SYSTEM WAS REMOVED ON (B)(6) 2010. THE EXPLANTED PRODUCTS WERE RETURNED TO THE MANUFACTURER ON 10/14/10. IT IS UNKNOWN WHETHER THE PATIENT WILL RECEIVE A REPLACEMENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 3158108

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention