BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3182167 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-06469
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-06468. IT WAS REPORTED DURING THE TRIAL LEADS REMOVAL THE SURGICAL INCISION SITE WAS RED WITH PUS ON THE SKIN SURFACE. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND TREATED WITH INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS THEN RELEASED AND PRESCRIBED ORAL ANTIBIOTICS. NO CULTURE WAS TAKEN. FOLLOW-UP IDENTIFIED THE PATIENT WAS SEEN BY HIS PHYSICIAN A WEEK LATER AND THE SURGICAL INCISION SITE IS COMPLETELY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270644 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL -NEUROMODULATION 3086 3956882

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other