BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1962789 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-02044
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 AN SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (OF THE SAME LOT), ON (B)(6) 2010. IT WAS REPORTED THE PT RECENTLY LOST STIMULATION. THE PT ATTEMPTED TO INCREASE THE AMPLITUDE, HOWEVER, EVEN AT MAXIMUM STIMULATION, THE PT CANNOT FEEL ANYTHING. THE PT WAS REFERRED TO HIS PHYSICIAN FOR REPROGRAMMING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. ACCORDING TO THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM, THE LEADS REMAIN IMPLANTED. NO FURTHER PT COMPLICATIONS WERE 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 3186 3097021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention