BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS TRIAL LEAD

    MDR report key: 2001056 · Received February 21, 2011

    Report

    Report Number
    1627487-2011-02229
    Event Type
    Injury
    Date Received
    February 21, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    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 RECEIVED HER TRIAL SCS SYSTEM, WHICH INCLUDED TWO PERCUTANEOUS TRIAL LEADS (OF THE SAME LOT), ON (B)(6) 2011. ON THE FOURTH DAY OF THE TRIAL, THE PT REPORTEDLY DEVELOPED A FEVER ALONG WITH DISCHARGE FROM THE LEAD INSERTION SITE. AS A RESULT OF THE INFECTION, THE LEADS WERE REMOVED AND DISCARDED AND THE TRIAL WAS ABORTED ONE DAY EARLY. THE PT WAS TREATED WITH ORAL ANTIBIOTICS. ON (B)(6) 2011, THE PT PRESENTED TO THE PHYSICIAN'S OFFICE FOR A ROUTINE F/U APPOINTMENT. AN EXAM OF THE PT NOTED HER FEVER HAD SUBSIDED BUT SOME SKIN BREAKDOWN WAS VISIBLE. ON (B)(6) 2011, THE PT DEVELOPED ANOTHER FEVER AND PRESENTED TO THE ER. THE PT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. IN ADDITION, AN MRI OF THE IMPLANT AREAS WAS PERFORMED. THE RESULTS OF THE MRI ARE NOT AVAILABLE. NEITHER THE MFG NOR THE EXP DATES WERE AVAILABLE. F/U ON THE PT FOUND NO FURTHER PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS TRIAL LEAD SPINAL CORD STIMULATION TRIAL LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3086 3234930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R