BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S MRI SURESCAN

    MDR report key: 10033255 · Received May 7, 2020

    Report

    Report Number
    2649622-2020-08951
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 13, 2020
    Report Date
    June 11, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169082267
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: A7700-29 MECHANICAL VALVE, IMPLANTED (B)(6) 1988. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DTBA1D4, CRT-D, IMPLANTED: (B)(6) 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE THE CLINICIAN WAS CONCERNED THAT THERE MAY BE A POSSIBLE LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV 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
    495841 SPRINT QUATTRO SECURE S MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62 00643169082267

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 419578 LEAD, 6725 ADAPTOR| 5076-52 LEAD, 383069 LEAD, DTMA1D4 CRT-D| 419578 LEAD, 6725 ADAPTOR