BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN PERFORMA MRI SURESCAN

    MDR report key: 20710443 · Received November 18, 2024

    Report

    Report Number
    2182208-2024-04915
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    July 4, 2024
    Report Date
    November 18, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: CLINICAL USEFULNESS OF THE ACTIVE FIXATION QUADRIPOLAR LEFT VENTRICULAR LEAD COMPARED WITH THE PASSIVE FIXATION QUADRIPOLAR LEAD IN CARDIAC RESYNCHRONIZATION THERAPY. CIRCULATION JOURNAL. 2024; 88: 1425-1431. DOI: 10.1253/CIRCJ.CJ-24-0084 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 A COMPARISON OF LEFT VENTRICULAR (LV) LEADS. THE AUTHORS DESCRIBED PATIENTS WHO EXPERIENCED PHRENIC NERVE STIMULATION AND LV LEADS WHICH EXHIBITED ELEVATED THRESHOLDS OR LEAD DISLODGMENT. THE STATUS OF THE LEADS IS UNKNOWN. REOPERATION WAS PERFORMED FOR LEAD DISLODGMENT AND REPROGRAMMING OR POLARITY CHANGES WERE PERFORMED ON OTHER LEADS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609766 ATTAIN PERFORMA MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MEDTRONIC, INC. 429888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H UNKNOWN CRT-D, UNKNOWN LEADS