BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTROD

    MDR report key: 2921787 · Received January 14, 2013

    Report

    Report Number
    1627487-2013-13072
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 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

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-13071. THE PATIENT HAD TWO LEADS FROM THE SAME LOT NUMBER AND ONE LEAD FROM ANOTHER LOT NUMBER. ALL LEADS ARE BEING REPORTED SINCE IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS EVENT. IT WAS REPORTED THE PATIENT HAD DIFFICULTY MOVING HER RIGHT LEG AFTER AN SCS IMPLANT PROCEDURE. THE PATIENT WAS TREATED WITH MEDICATION. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THE RIGHT LEAD AND INSERT A NEW LEAD. FOLLOWING THE PROCEDURE, THE PATIENT'S RIGHT LEG WAS A LITTLE SORE, THE PHYSICIAN ATTRIBUTED THE PATIENT'S SORENESS TO INFLAMED NERVES. THE PATIENT WAS REPROGRAMMED AND HAD EFFECTIVE STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20909 OCTROD SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3855477

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788