BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2120231 · Received June 7, 2011

    Report

    Report Number
    1627487-2011-01612
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED AN SCS TRIAL SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2009. IT WAS REPORTED THAT STIMULATION COVERAGE WAS UNABLE TO BE OBTAINED POSTOPERATIVE, AND THE PATIENT DEMANDED THAT THE LEADS BE REMOVED. THE PHYSICIAN EXPLANTED THE LEADS ON (B)(6) 2009. THE EXPLANTED LEADS WERE DISCARDED BY THE FACILITY. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM LATER THAT DAY, AND IT WAS DISCOVERED THAT HE HAD AN EPIDURAL HEMATOMA. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 2777749

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R