BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1970970 · Received January 6, 2011

    Report

    Report Number
    1627487-2011-00010
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 4, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD: THE DEVICE HISTORY STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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 A PERCUTANEOUS LEAD ON (B)(6) 2007. IT WAS REPORTED THAT ONLY ONE OF THE PT'S FOUR SET PROGRAMS IS PROVIDING EFFECTIVE STIMULATION AND THAT HE IS UNABLE TO INCREASE THE AMPLITUDE FOR THE OTHER THREE. AN APPOINTMENT WILL BE SCHEDULED FOR PURPOSES OF REPROGRAMMING. IN THE INTERIM, THE PT WILL UTILIZE THE FUNCTIONING PROGRAM FOR THERAPY RELIEF. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILARLY REPORTED EVENTS HAVE LED TO THE EXPLANT OF THE LEAD.

    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 64606

    Patients

    Seq Age Sex Outcome Treatment
    1