BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2020418 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-00167
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00168. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010 INCLUDING TWO PERCUTANEOUS LEADS FOR UNILATERAL LEG PAIN. IT WAS REPORTED THAT THE PT BELIEVED SHE HAD A LEAD FRACTURE. AN X-RAY OF HER SCS SYSTEM WAS TAKEN; HOWEVER, NO VISIBLE ANOMALIES WERE OBSERVED. IT WAS REPORTED THAT THE PT IS RECEIVING STIMULATION TO THE INTENDED COVERAGE AREA VIA ONE OF HER LEADS, BUT THE SECOND DEVICE IS ALLEGEDLY NOT PROVIDING THERAPY DUE TO IMPEDANCE ISSUES. AT THIS TIME, THERE ARE NO PLANS FOR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3186 3155033

    Patients

    Seq Age Sex Outcome Treatment
    1