BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS TRIAL LEAD

    MDR report key: 2201535 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-02914
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    THE PT RECEIVED A TRIAL SCS SYS ON (B)(6) 2011. IT WAS REPORTED THAT DURING THE TRIAL, THE IMPEDANCE READINGS WERE VERY HIGH ON ONE LEAD AND THE PT COULD NOT FEEL STIMULATION. THE LEAD WAS REPLACED AND THE PT CAN FEEL STIMULATION THROUGH THE NEW LEAD. THE EXPLANTED LEAD WAS RETURNED TO THE MFR FOR ANALYSIS. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS TRIAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3350864

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention