BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2840199 · Received November 13, 2012

    Report

    Report Number
    1627487-2012-00754
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    IT WAS REPORTED TWO OF THE PT'S ((B)(6)) THREE PROGRAMS ARE NOT PRODUCING EFFECTIVE THERAPY RELIEF. A DIAGNOSTIC TEST DID NOT REVEAL ANY ISSUES WITH RESPECT TO IMPEDANCE. THE PT HAS REPORTEDLY BEEN ENGAGED IN VIGOROUS PHYSICAL ACTIVITY (SWIMMING). LEAD MIGRATION IS SUSPECTED AS THE CONTOUR OF THE LEAD IS VISIBLE UNDER THE PT'S SKIN. REPROGRAMMING WAS UNDERTAKEN TO INCREASE THE PERCEPTION LEVEL FOR TWO OF THE PT'S PROGRAMS. AN X-RAY HAS BEEN ORDERED FOR FURTHER INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3517922

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3688