BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE SVC LEAD

    MDR report key: 10494329 · Received September 4, 2020

    Report

    Report Number
    2182208-2020-01751
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    June 1, 2020
    Report Date
    September 4, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS VARIABLE. CONCOMITANT MEDICAL PRODUCTS: 693565, LEAD, IMPLANTED: (B)(6) 2010; 407652, LEAD, IMPLANTED: (B)(6) 2010; D364DRG, ICD, IMPLANTED: (B)(6) 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A JUMP IN IMPEDANCE VALUES WITH THE SUPERIOR VENA CAVA (SVC) LEAD, REACHING HIGH/UNDEFINED LEVELS. THE LEAD WAS PROGRAMMED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958878 TRANSVENE SVC LEAD DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6937-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 407658 LEAD