BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2843409 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-13087
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 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: 1627487-2012-13084. IT WAS REPORTED DURING THE LEAD REMOVAL AT THE END OF THE PATIENT'S TRIAL PERIOD, THE PHYSICIAN NOTED SIGNS OF INFECTION AT THE LEAD INSERTION SITE. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS. FOLLOW-UP INDICATED THE PATIENT'S INFECTION HAD RESOLVED ITSELF AFTER TAKING THE ANTIBIOTICS. THERE WERE TWO LEADS FROM DIFFERENT LOT NUMBERS, SUBMITTING REPORT FOR BOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3782256

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention