BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2092565 · Received May 3, 2011

    Report

    Report Number
    1627487-2011-02540
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROSTIMULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AN SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2011. IT WAS REPORTED THE PT'S LEAD WAS SURGICALLY REVISED DUE TO MIGRATION AND A LOSS OF STIMULATION. INTRAOPERATIVE TESTING FOUND ONLY THREE OF THE EIGHT LEAD CONTACTS HAD ACCEPTABLE IMPEDANCE. AS THE PHYSICIAN WAS ABLE TO CAPTURE STIMULATION VIA THE THREE WORKING CONTACTS, THE LEAD WAS LEFT IMPLANTED. NO FURTHER PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROSTIMULATION 3186 3113043

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MODEL: SJM IPG| IMPLANT:| SCS IPG