BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2934298 · Received January 7, 2013

    Report

    Report Number
    1627487-2013-00039
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    September 1, 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
    GM
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-00038. IT WAS REPORTED THAT ALTHOUGH STIMULATION IS BEING DELIVERED TO THE APPROPRIATE TARGET AREAS, THE PT ((B)(6)) IS NOT RECEIVING EFFECTIVE PAIN RELIEF. THE PT'S SCS SYSTEM IS SAID TO BE FUNCTIONING AS DESIGNED. THERE ARE NO PLANS FOR SURGICAL INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8535 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention