BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 8080394 · Received November 16, 2018

    Report

    Report Number
    2649622-2018-18868
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 26, 2018
    Report Date
    November 16, 2018
    Manufacturer
    MPRI
    Product Code
    NVY
    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: 5076-52 LEAD, IMPLANTED: (B)(6) 2011. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SUPERIOR VENA CAVA (SVC) IMPEDANCE. THE LEAD WAS PROGRAMMED OFF AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920536 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DDMC3D4 ICD