BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 3931771 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-26524
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    December 24, 2013
    Report Date
    June 3, 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

    DEVICE #1 OF 2 REFERENCE MFR. REPORT: 1627487-2014-26525. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS. REPROGRAMMING WAS ABLE TO INITIALLY PROVIDE EFFECTIVE COVERAGE. HOWEVER, ON (B)(6) 2014 THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED. THE PATIENT IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367349 LAMITRODE 44 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3262 3593615

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: