BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 7022427 · Received November 10, 2017

    Report

    Report Number
    3006705815-2017-01630
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 14, 2017
    Report Date
    January 8, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DHR REVIEW SUMMARY RESULTS: SUMMARY FINAL PACKAGING LEVEL: FINAL PACKAGING PRODUCTION RECORD FOR 65-3186 BATCH # A000043997 SHOWED LOT # 6010122-262, 6032525-32 AND 6016175-80 WERE REWORKED UNDER 90223613/J. NO NONCONFORMANCES WERE RECORDED. STERILITY LEVEL: STERILITY RECORD FOR STERILE LOT PRA05657 SHOWED NO NONCONFORMANCES RECORDED. CONCLUSION NO NONCONFORMANCES RECORDED IN THE BATCH RECORDS REVIEWED. IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2: REFERENCE MFR. REPORT#: 3006705815-2017-01631. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE INFECTION HAS RESOLVED.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 3006705815-2017-01631. IT WAS REPORTED THAT THE PATIENT HAS A POSSIBLE INFECTION AT THE LEAD SITE POST-OP. AN ANTIBIOTIC INFUSION WAS ADMINISTERED AND A BIOPSY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798609 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000043997

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other