BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2934289 · Received January 7, 2013

    Report

    Report Number
    1627487-2013-04030
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    IT WAS REPORTED THE PT HAD LOST STIMULATION, AND WAS UNABLE TO COMMUNICATE WITH THE SYSTEM USING THE PT PROGRAMMER. THE SJM REPRESENTATIVE MET WITH THE PT AND DETERMINED ALL OF THE CONTACTS ON THE LEAD SHOWED HIGH IMPEDANCES. FOLLOW UP WITH THE PT IDENTIFIED THE PT HAD HEALTH ISSUES UNRELATED TO THE SCS SYSTEM, AND IT WAS REPORTED THE PT WOULD FOLLOW UP WITH HIS PHYSICIAN REGARDING THE STIMULATION AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8497 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3554261

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3716