BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 9309662 · Received November 12, 2019

    Report

    Report Number
    2649622-2019-20852
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 24, 2019
    Report Date
    February 10, 2020
    Manufacturer
    MPRI
    Product Code
    NVY
    UDI-DI
    00643169356610
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS INDICATED THE EXPOSED SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS COVERED IN MEDICAL ADHESIVE. THE EXPOSED SUPERIOR VENA CAVA DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE EXPOSED SUPERIOR VENA CAVA DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD GOT CAUGHT UP IN THE INTRODUCER AND THE CONDUCTOR COIL WAS STRETCHED. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106759 SPRINT QUATTRO SECURE MRI SURESCAN DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55 00643169356610

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR