BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 4

    MDR report key: 2792113 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-02471
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 18, 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

    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

    THE PATIENT RECEIVED TWO LEADS (FROM THE SAME LOT) IN THE OCCIPITAL REGION (OFF-LABEL). IT WAS REPORTED THE PATIENT DEVELOPED A (B)(6) INFECTION AT HER LEAD INCISION SITE. THE PHYSICIAN CONSEQUENTLY REMOVED THE PATIENT'S ENTIRE SYSTEM. IT WAS REPORTED THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. FOLLOW-UP ON THE PATIENT FOUND THE INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 4 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3254 3253513

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: