BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 8116685 · Received November 29, 2018

    Report

    Report Number
    2649622-2018-19557
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 29, 2018
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 HAD HIGH/UNDEFINED IMPEDANCE ON THE RV COIL AND SCV COIL. REPROGRAMMING WAS PERFORMED TO TURN THE HIGH VOLTAGE PORTION OF THE LEAD OFF UNTIL THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956416 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R