BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIA MRI QUAD CRT-D

    MDR report key: 8257094 · Received January 17, 2019

    Report

    Report Number
    3004209178-2019-01195
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 24, 2018
    Report Date
    February 13, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169929562
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0962-2017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: R770029, MECHANICAL VALVE, IMPLANTED: (B)(6) 2007. 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. THE DEVICE WAS RETURNED AND SCREENING ANALYSIS WAS PERFORMED, BUT NO ISSUE WAS IDENTIFIED REQUIRING FULL ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SEPSIS SYNDROME AND WAS BROUGHT TO THE HOSPITAL WITH AN EPISODE OF MULTI-SYSTEM ORGAN FAILURE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED ENDOCARDITIS. THE INFECTED AORTIC VALVE WAS THOUGHT TO HAVE VEGETATION AND THE VALVE WAS REMOVED AND A PORTION OF THE AORTIC GRAFT AND IMPLANTATION OF A HOMOGRAFT AORTIC VALVE AND AORTA. THE DEVICE AND LEADS WERE EXPLANTED. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49493 CLARIA MRI QUAD CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTMA1QQ 00643169929562

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R 5076-52 LEAD, 479888 LEAD, 6935M62 LEAD