BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44C

    MDR report key: 3193587 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-10214
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    IT WAS REPORTED THE PT ((B)(6)) WAS NO LONGER FEELING STIMULATION. DIAGNOSTIC TESTING IDENTIFIED IMPEDANCE ISSUES AND X-RAY IMAGERY REVEALED A BREAK IN THE SCS LEAD. THE LEAD WAS EXPLANTED AND REPLACED WHICH RESOLVED THE REPORTED ISSUE. EFFECTIVE STIMULATION WAS RESTORED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288312 LAMITRODE 44C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3245 3736458

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other