BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 11952327 · Received June 7, 2021

    Report

    Report Number
    2649622-2021-11328
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 21, 2021
    Report Date
    May 28, 2024
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169550766
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ADDITIONAL 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 FURTHER 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).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28 LEAD, IMPLANTED: (B)(6) 2015, PRODUCT ID: 3058 IPG, IMPLANTED: (B)(6) 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD AND RIGHT ATRIAL (RA) LEAD DISLODGED AND WERE EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846162 CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MPRI 5076-52 00643169550766

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization| R 439888 LEAD, DTBA1QQ CRT-D, 6935M55 LEAD