BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2182612 · Received July 5, 2011

    Report

    Report Number
    1627487-2011-00913
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 6, 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 2 OF 2. REF MFR REPORT # 1627487-2011-00912. THE PT RECEIVED AN SCS SYSTEM INCLUDING DUAL PERCUTANEOUS LEADS FROM DIFFERENT LOTS ON (B)(6) 2009 FOR RIGHT FOOT PAIN. IT WAS REPORTED THAT THE PT WAS EXPERIENCING A BURNING SENSATION IN HER LEG, THIGH AND BUTTOCKS. A DIAGNOSTIC TEST REVEALED LOW IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. AN X-RAY WAS ALSO TAKEN; HOWEVER, NO VISUAL ANOMALIES WERE OBSERVED. THE PT IS CURRENTLY WORKING CLOSELY WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION IN THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2798826

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention SCS LEADS: MODEL 3186 X2| LEAD ANCHORS: MODEL 1194| IMPLANTED:| SCS IPG: MODEL 3788| IMPLANTED:| IMPLANTED: