BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2831924 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-11657
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT HAD STIMULATION AT THE RIBS ON HIS RIGHT SIDE. THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING AND WAS ABLE RESOLVE THE RIB STIMULATION. I WAS REPORTED RIGHT SIDED LEG PAIN WAS COVERED WITH THE STIMULATION, BUT LEFT LEG RELIEF WAS NOT OBTAINED. THE IMPEDANCES ON THE LEAD WERE WITHIN THE NORMAL RANGE. X-RAYS WERE PERFORMED WHICH SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 86428

    Patients

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