BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2002325 · Received January 27, 2011

    Report

    Report Number
    1627487-2011-02100
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2009. IT WAS REPORTED THE PT IS RECEIVING INTERMITTENT STIMULATION WITH OCCASIONAL OVERSTIMULATION FROM THE SYSTEM. A DIAGNOSTIC CHECK OF THE LEAD FOUND HIGH IMPEDANCES ON SOME CONTACTS. THE PHYSICIAN WAS ABLE TO ADJUST THE PT'S PROGRAM TO ENSURE THOSE CONTACTS WERE NOT USED. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES 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 2796192

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention