BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1990689 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-02151
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVAL: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF LEAD MIGRATION COULD NOT BE CONFIRMED VIA LAB TESTING. 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 RECEIVED HER SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2010. IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED DUE TO MIGRATION. THE EXPLANTED LEAD WAS RETURNED TO THE MFR FOR ANALYSIS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3189 2898324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention