BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 19126983 · Received April 17, 2024

    Report

    Report Number
    3008973940-2024-02763
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    January 1, 2023
    Report Date
    April 17, 2024
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. REFERENCED ARTICLE: PREDICTORS OF THE RIGHT VENTRICULAR PERFORATION CAUSED BY ACTIVE-FIXATION PACING AND DEFIBRILLATOR LEADS: A SING LE-CENTRE EXPERIENCE. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY (JCE). 2024; 35:399¿405. DOI: 10.1111/JCE.16181. 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

    LITERATURE WAS REVIEWED REGARDING RIGHT VENTRICULAR (RV) LEAD PERFORATION. THE AUTHORS DESCRIBED PATIENTS WITH CLINICAL SIGNS OF PERFORATION AND AN URGENT TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED TO IDENTIFY THE PRESENCE OF PERICARDIAL FLUID OR TAMPONADE. PATIENTS THEN UNDERWENT ENHANCED CARDIAC COMPUTERIZED TOMOGRAPHY (CT) SCANS. ONE PATIENT EXPERIENCED A PERFORATION AND REQUIRED SURGICAL REMOVAL OF THE PERFORATED RV LEAD. THE STATUS OF THE LEAD IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855715 CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L| H UNKNOWN CIED