BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2002338 · Received January 27, 2011

    Report

    Report Number
    1627487-2011-02105
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 RECEIVED AN SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (OF THE SAME LOT), ON (B)(6) 2010. IT WAS REPORTED THE PT NOTICED A CHANGE IN HER STIMULATION SHORTLY AFTER FALLING. AS THE PHYSICIAN SUSPECTED LEAD MIGRATION, A LEAD REVISION WAS RECOMMENDED. FOLLOW UP ON THE PT FOUND THAT SHE HAS DECLINED A LEAD REVISION AT THIS TIME. THE LEADS REMAIN IN USE.

    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 3062358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention