BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 8784440 · Received July 12, 2019

    Report

    Report Number
    2649622-2019-12089
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 15, 2019
    Report Date
    August 5, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00613994249890
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2009. 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 RIGHT VENTRICULAR DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE OF THE SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. 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 LEAD HAD IMPEDANCE SPIKES ON BOTH HIGH-VOLTAGE COILS AND AN ALERT WAS TRIGGERED; THE LEAD HAD A POSSIBLE FRACTURE. THE LEAD WAS PARTIALLY EXPLANTED, CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577795 SPRINT QUATTRO SECURE MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765 00613994249890

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DTBA1Q1 CRTD, 4298-88 LEAD