BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2180642 · Received May 5, 2011

    Report

    Report Number
    1627487-2011-02543
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 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 INFORMATION 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 REC'D HER SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (OF THE SAME LOT), ON (B)(6) 2007. IT WAS REPORTED THAT THE PT UNDERWENT A MEDICAL PROCEDURE WHICH REQUIRED MANIPULATION OF HER BODY. SINCE THAT TIME, THE PT ADVISED, SHE HAS NOT FELT ANY STIMULATION FROM HER SCS SYSTEM. THE PT IS WORKING CLOSELY WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 84809

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788