BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE S8

    MDR report key: 3963622 · Received May 30, 2014

    Report

    Report Number
    1627487-2014-00323
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THIS LEAD WAS INTENDED FOR IMPLANT IN (B)(6). DURING THE IMPLANT PROCEDURE, INTRAOPERATIVE TESTING FOUND INVALID IMPEDANCE MEASUREMENTS FOR THREE LEAD CONTACTS. EFFORTS TO RESOLVE THIS ISSUE THROUGH TROUBLESHOOTING WERE UNSUCCESSFUL. A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319803 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 4214424

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK