BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2033503 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-00393
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 TWO PERCUTANEOUS LEADS ON (B)(6) 2006 FOR BILATERAL LEG PAIN. IT WAS REPORTED THAT HE LOST STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN TO RECTIFY THIS MATTER. INTRAOPERATIVE TESTING REVEALED THAT ONE OF THE LEADS EXHIBITED INVALID IMPEDANCE MEASUREMENTS. THE LEAD IN QUESTION WAS REPLACED AND EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3186 55542

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention