BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS TRIAL LEAD

    MDR report key: 1910858 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03324
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 30, 2010
    Report Date
    October 30, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    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 HAD A SCS TRIAL PROCEDURE ON (B)(6) 2010. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO IMPLANT A TRIAL LEAD AT T8-T9. HOWEVER, DUE TO ADHESIONS/SCAR TISSUE, THE PHYSICIAN WAS UNABLE TO INSERT THE LEAD INTO THE EPIDURAL SPACE. HE ATTEMPTED TO INSERT THE LEAD AT THREE DIFFERENT VERTEBRAL LEVELS WITHOUT SUCCESS. ULTIMATELY, THE CASE WAS ABORTED AND THE PHYSICIAN DISCARDED THE LEAD. THE PATIENT REPORTED THAT THE TRIAL PROCEDURE TOOK TWO HOURS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention