BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2926098 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-02104
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 27, 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

    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 3 OF 4. REFERENCE MFR REPORTS: 1627487-2013-02102, 02103, AND 02105. THE PATIENT RECEIVED AN OCCIPITAL LEAD (OFF-LABEL) AND A THORACIC LEAD AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PATIENT DEVELOPED A FEVER, REDNESS AND SWELLING AT HER IPG AND LEAD SITES. THE PHYSICIAN CONSEQUENTLY REMOVED HER SYSTEM ON (B)(6) 2012. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND CULTURE RESULTS REVEALED STAPHYLOCOCCAL INFECTION. FOLLOW-UP INDICATED THE PATIENT RECOVERED FROM THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25406 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3757714

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention