BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2241203 · Received August 18, 2011

    Report

    Report Number
    1627487-2011-07070
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT 1627487-2011-07073. THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2011 CONSISTING OF 2 LEADS FROM DIFFERENT LOTS. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT HAS NO STIMULATION AND A LOW IMPEDANCE READING WAS OBSERVED. THERE ARE NO REPORTS OF PT FALL AND THE PT CHARGER IS ABLE TO LOCATE THE PT PROGRAMMER (PP) AND IPG. PT FOLLOW UP INDICATED REPROGRAMMING PROVIDED THE PT THE STIMULATION IN THE AREAS NEEDED. THE PT IS SATISFIED WITH THE RESULT AND STIMULATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3101861

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SCS IPG: MODEL 3788