BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 8541813 · Received April 23, 2019

    Report

    Report Number
    3004209178-2019-08100
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    March 28, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A290, SERIAL/LOT #: (B)(4), UBD: 19-OCT-2022, UDI #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE RETURNED LEAD SEGMENT (SERIAL # (B)(4)) FOUND BROKEN CONDUCTORS IN THE DISTAL END. THE DISTAL SEGMENT OF THE LEAD WAS RECEIVED FOR ANALYSIS. NO OTHER SEGMENTS WERE RECEIVED. VISUAL INSPECTION OF THE CONNECTOR END AND SETSCREW MARKS COULD NOT BE PERFORMED AS THE PROXIMAL END OF THE LEAD WAS NOT RETURNED. INSPECTION OF THE CONDUCTORS VERIFIED THAT THE LEAD WAS CUT. THE # 5 AND 6 CONDUCTOR WIRES WERE FRACTURED IN THE ELECTRODE WELD AT THE ELECTRODE WELD SITE. THE OUTER INSULATION WAS CUT THROUGH. THE BRAID WAS CUT. THE STYLET COIL WAS CUT THROUGH. THE ELECTRODE END WAS INTACT AND UNDAMAGED. ELECTRICAL TESTING DETERMINED THAT THE CONTINUITY OF THE CONDUCTORS WAS NOT COMPLETE. CIRCUITS # 5 AND 6 WERE OPEN. CIRCUITS # 0-4 AND 7 HAD ACCEPTABLE CONTINUITY. THERE WERE NO SHORTS OBSERVED BETWEEN THE CONDUCTORS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A NEURO STIMULATOR. IT WAS REPORTED THAT HIGH IMPEDANCE WAS MEASURE ON CERTAIN POLES OF THE LEAD. REPROGRAMMING WAS DONE EXCLUDING THE HIGH IMPEDANCE POLES. THE LEAD WAS EXPLANTED. IT WAS UNKNOWN IF THE ISSUE RESOLVED. NO SYMPTOMS WERE REPORTED, AND THE PATIENT WAS ALIVE WITH NO INJURY. THE ISSUE OCCURRED DURING NORMAL USE. TWO SESSION REPORTS WERE PROVIDED. THE REPORT FROM (B)(6) 2019 SHOWED MULTIPLE PAIRS WITH HIGH IMPEDANCE OF 40000 OHMS, OTHER PAIRS WITH HIGH IMPEDANCE RANGING FROM 15610-16250 OHMS, AND OTHER PAIRS WITH NORMAL IMPEDANCE RANGING FROM 790-1080 OHMS. THERE WERE NO IMPEDANCE RESULTS IN THE REPORT FROM (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335527 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention