BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2993983 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-10072
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED INTRA-OPERATIVE TESTING REVEALED INVALID CONTACTS ON THE SURGICAL SCS LEAD ((B)(6)) THE PHYSICIAN REMOVED THE SURGICAL LEAD AND COMPLETED THE PROCEDURE USING TWO PERCUTANEOUS LEADS. THE ENTIRE PROCEDURE TOOK 3.5 HOURS TO COMPLETE. IT WAS NOTED THAT THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS AS A RESULT OF THE PROCEDURE. EFFECTIVE STIMULATION WAS ACHIEVED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89447 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3690032

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention