BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA¿ QUAD XT CRT-D

    MDR report key: 19408058 · Received May 28, 2024

    Report

    Report Number
    3004209178-2024-11699
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 21, 2021
    Report Date
    May 28, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. REFERENCED ARTICLE: CASE REPORT: LEAD MACRO DISLODGEMENT: AN UNUSUAL CASE OF LATE-ONSET REEL SYNDROME. CJC OPEN. 2024. 6;104-107. DOI: 10.1016/J.CJCO.2023.11.012 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LITERATURE ARTICLE THAT BOTH THE LV AND RA LEADS EXHIBITED AN INCREASE IN THRESHOLDS. RADIOGRAPHS PERFORMED AT THE OFFICE VISIT SHOWED THE MIGRATION OF THE RA AND LV LEADS INTO THE SUPERIOR VENA CAVA - RA JUNCTION AND THE LEADS APPEARED TO BE COILED AROUND THE DEVICE. IN ADDITION, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD MIGRATED FROM ITS ORIGINAL LOCATION. THE DEVICE WAS EXPLANTED ALONG WITH THE LEADS DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229920 VIVA¿ QUAD XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female 5076-52 LEAD, 439888 LEAD, 6935M55 LEAD