BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIA MRI QUAD CRT-D SURESCAN

    MDR report key: 8663870 · Received June 3, 2019

    Report

    Report Number
    9614453-2019-01796
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 16, 2019
    Report Date
    July 19, 2019
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    UDI-DI
    00763000059514
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO AN INFECTION OF THE AORTIC VALVE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458073 CLARIA MRI QUAD CRT-D SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTMA1QQ 00763000059514

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 6935M55 LEAD, 439888 LEAD, 6725 ADAPTOR