BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3192115 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-04788
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    October 3, 2012
    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
    MD, 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 BEEN IN A AUTOMOBILE ACCIDENT IN WHICH HE WAS REAR ENDED. THE PATIENT REPORTED THE STIMULATION HAD CHANGED. FOLLOW UP IDENTIFIED THE PHYSICIAN IMPLANTED A NEW SCS SYSTEM ON (B)(6) 2013 FOR PERIPHERAL PURPOSE AND THE EXISTING SCS SYSTEM WAS LEFT IMPLANTED. IT WAS REPORTED THE PATIENT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281077 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3577043

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788