BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2150784 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-01669
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    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

    THE PT ((B)(6)) RECEIVED HER SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION, AND THE AMPLITUDE ON THE PROGRAMMER STOPPED AT PERCEPTION ON ALL PROGRAMS. DIAGNOSTIC TESTS REVEALED HIGH IMPEDANCE MEASUREMENTS ON SEVERAL LEAD CONTACTS. THE PT WAS REPROGRAMMED WITHOUT USING THE AFFECTED CONTACTS, AND GOOD STIMULATION COVERAGE WAS REPORTED. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    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 2847790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention