BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA LEAD

    MDR report key: 1852330 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02622
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. RESULTS - UPON VISUALIZATION, THE DUAL-TAILED LEAD WAS RETURNED INCOMPLETE. THE LEAD WAS CUT AT THE TERMINAL END. TOP CHANNEL 15 ELECTRODE IS MISSING FROM THE PADDLE. THERE WAS DISCOLORATION IN THE LEAD PADDLE. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO INCOMPLETE LEAD. CONCLUSION - COMPLAINT ABOUT "SERIOUS INJURY" COULD NOT BE CONFIRMED; AS RECEIVED THE LAMITRODE WAS INCOMPLETE AND CUT AT THE TERMINAL END. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO INCOMPLETE LAMITRODE. ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS SCHEDULED TO BE IMPLANTED WITH AN SCS SYSTEM. THE DOCTOR PERFORMED A LAMINECTOMY, INSERTED THE LEAD AND OBSERVED A DURAL LEAK (FLUID CAME OUT OF THE LOCATION WHERE THE LEAD WAS BEING INSERTED). THE DOCTOR REMOVED THE LEAD AND FIXED THE LEAK. THE DOCTOR IMPLANTED A NEW LEAD WITHOUT ANY DIFFICULTIES. THE PATIENT WAS GETTING GOOD STIMULATION POST-OP. THE PATIENT HAD NO SYMPTOMS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA LEAD SPINAL CORD, STIMULATION (PAIN RELIEF) LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3228 3136518

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other