BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 4023220 · Received August 15, 2014

    Report

    Report Number
    1627487-2014-25555
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    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

    IT WAS REPORTED THE PATIENT ((B)(6)) LOST STIMULATION. LEAD DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ALL CONTACTS. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT AND REPLACE (DIFFERENT MODEL) THE LEAD WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490197 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCS ANCHOR: MODEL 1192| IMPLANT DATE: UNK