BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 3926162 · Received June 2, 2014

    Report

    Report Number
    1627487-2014-02389
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    IT WAS REPORTED THE PT CONTACTED SJM AND STARTED HIS SCS LEAD WAS EXPOSED. THE PT WAS ADVISED TO GO TO THE ER AND NOTIFY HIS PHYSICIAN. IT WAS DETERMINED THE PT'S SCS LEAD HAD ERODED THROUGH THE SKIN. THE PT'S SCS SYSTEM WAS REMOVED. NO SIGNS OF INFECTION WERE FOUND. IN ADDITION, THE PT IS REPORTEDLY DOING WELL POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320913 LAMITRODE TRIPOLE 16C SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3214 2864830

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 33788| SCS ANCHOR: MODEL 1194 (X2)