BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2062211 · Received March 17, 2011

    Report

    Report Number
    1627487-2011-02311
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-02310. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS ON (B)(6) 2007. IT WAS REPORTED THE PATIENT IS NO LONGER FEELING STIMULATION. THE STIMULATION CAN BE INCREASED TO A MAXIMUM AMPLITUDE BUT THE PATIENT REPORTEDLY ONLY FEELS A FAINT STIMULATION. DIAGNOSTIC TESTING OF THE LEAD FOUND THAT FIVE OF THE EIGHT CONTACTS HAD LOW IMPEDANCES. THE LOT NUMBER FOR THE LEAD IN QUESTION WAS NOT PROVIDED; THEREFORE, A REPORT HAS BEEN SUBMITTED FOR BOTH THE PATIENT'S LEADS. THE PATIENT IS CURRENTLY WORKING WITH HIS PHYSICIAN TO ARRANGE AN X-RAY WHICH WILL HELP TO DETERMINE THE NEXT COURSE OF ACTION.

    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 57786

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention