BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 13261956 · Received January 14, 2022

    Report

    Report Number
    2649622-2022-01048
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 28, 2021
    Report Date
    January 14, 2022
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: DTMB2D1 ICD, IMPLANTED: (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS INTERMITTENT ECTOPIC BEATS WITH THE RIGHT VENTRICULAR (RV) LEAD ONLY CAPTURING EVERY OTHER BEAT. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808065 SPRINT QUATTRO SECURE MRI SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male 5076 LEAD, 4296-78 LEAD.