BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1910909 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03637
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    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 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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2010-03636. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2008. IT WAS REPORTED THAT DURING A BACK SURGERY, THE PHYSICIAN INADVERTENTLY CUT THE PT'S SCS LEADS. AS A RESULT, THE PT LOST STIMULATION FROM HIS SYSTEM. THE LEADS WERE EXPLANTED AND REPLACED. THE EXPLANTED LEADS WERE NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AS THEY WERE DISCARDED BY THE FACILITY. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES 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 172806

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention