BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3192077 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-00345
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 (B)(6) IS A PARTICIPANT IN A CLINICAL STUDY. IT WAS REPORTED THE PATIENT HAS EXPERIENCED SWELLING AT THE SITE OF ONE OF THE LEADS. THIS ISSUE HAS REPORTEDLY RESULTED IN DISCOMFORT AS THE SITE IS SENSITIVE TO TOUCH AND IS PROHIBITING THE PATIENT FROM SLEEPING IN CERTAIN POSITIONS. FOLLOW-UP ON THIS MATTER FOUND THAT A CONSULTATION WITH THE NEUROSURGEON WAS CONDUCTED. THERE ARE NO PLANS FOR INVASIVE OR MEDICINAL INTERVENTION. THE PATIENT HAS MADE NO RECENT CLAIMS OF CONTINUANCE OF THE REPORTED SWELLING OR DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281095 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3183 3910796

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other SCS IPG, MODEL: 3788| IMPLANT DATE: