BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3862817 · Received May 23, 2014

    Report

    Report Number
    1627487-2014-26438
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 2, 2014
    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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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 #1 OF 3. REFERENCE MFR REPORT: 1627487-2014-26439 AND 1627487-2014-26446. IT WAS REPORTED THE PT EXPERIENCED AN INFECTION AND CELLULITIS AT THE LEAD SITE. A CT SCAN WAS TAKEN AFTER THE PT PRESENTED TO THE CLINIC WITH PUS AND DRAINAGE AT LEAD INCISION SITE. THE CT WAS NEGATIVE FOR AN ABSCESS. THE PT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THE ENTIRE SCS SYSTEM. A CULTURE WAS TAKEN AND WAS NEGATIVE FOR INFECTION. THE PT WAS GIVEN ORAL ANTIBIOTICS. THE WOUNDS WERE LEFT OPEN AND PACKED WITH ANTIBACTERIAL GAUZE AND WILL FOLLOW UP WITH WOUND CARE. INFECTION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309200 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2787306

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other