BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3192097 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02860
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02861. IT WAS REPORTED THE PATIENT DOES NOT USE HIS SCS SYSTEM AS IT DOES NOT HELP WITH HIS PAIN. HE STATED HE HAD BEEN REPROGRAMMED SEVERAL TIMES, BUT EFFECTIVE STIMULATION COULD NOT BE ACHIEVED. HE ALLEGED DURING THE IMPLANT PROCEDURE THE PHYSICIAN HAD EXPERIENCED DIFFICULTY PLACING THE LEAD DUE TO SCAR TISSUE. THE SJM REP OFFERED TO MEET WITH PATIENT, BUT HE WAS NOT INTERESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281070 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3186 3444720

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788