BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NMD SURGICAL LEAD

    MDR report key: 1910348 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03332
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 WAS IMPLANTED WITH A PERCUTANEOUS LEAD IN (B)(6) 2008 FOR FOOT PAIN RELIEF. IT WAS REPORTED THAT SHE UNDERWENT AN ELECTIVE REPLACEMENT ON (B)(6) 2010 FOR PADDLE LEAD PLACEMENT. EFFECTIVE STIMULATION COULD NOT BE OBTAINED INTRAOPERATIVELY AND THE PT COMPLAINED OF INTENSE PAIN. THE PROCEDURE WAS ABORTED, AND ALL LEADS ASSOCIATED WITH THIS CASE WERE DISCARDED. THE PT WAS ALLEGEDLY UNABLE TO WALK FOR DAYS AFTERWARD. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NMD SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1