BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2133565 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-00826
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS: THE RETURNED LEAD FAILED FUNCTIONAL TESTING AS TWO CHANNELS MEASURED OPEN. 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 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00827. THE PT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD AND A LEAD EXTENSION. IT WAS REPORTED THAT THE PT LOST STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN TO ADDRESS THIS ISSUE. THE PHYSICIAN REPLACED THE PT'S EXTENSION; HOWEVER, THE REPORTED PROBLEM PERSISTED. AS SUCH, THE PHYSICIAN DECIDED TO REPLACE THE LEAD AS WELL. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT, AND NO FURTHER ISSUES WERE REPORTED.

    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 3121672

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL UNK| IMPLANTED: