BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2052059 · Received March 1, 2011

    Report

    Report Number
    1627487-2011-00259
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    THE PT WAS IMPLANTED WITH DUAL PERCUTANEOUS LEADS ON (B)(6) 2010 FOR LEFT HIP AND LEG TO FOOT PAIN. IT WAS REPORTED THAT THE PT WAS UNABLE TO INCREASE THE AMPLITUDE OF HIS STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE READINGS FOR TWO LEAD CONTACTS. THE PT'S SCS SYSTEM WAS REPROGRAMMED; HOWEVER, THE RESULTING THERAPY COVERAGE PROVED INADEQUATE. A SUBSEQUENT X-RAY REVEALED THAT ONE OF HIS LEADS WAS BENT. FOLLOW-UP ON THIS MATTER FOUND THAT ADEQUATE THERAPY COVERAGE HAS BEEN ACHIEVED FOR THE PT FOLLOWING HIS MOST RECENT REPROGRAMMING SESSION. THERE ARE NO IMMEDIATE PLANS FOR SURGICAL INTERVENTION AT THIS TIME.

    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 DIVISION 3186 3153749

    Patients

    Seq Age Sex Outcome Treatment
    1