BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA MRI SURESCAN

    MDR report key: 22394638 · Received July 3, 2025

    Report

    Report Number
    2649622-2025-18012
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 11, 2025
    Report Date
    July 3, 2025
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169601833
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0185 LEAD <(>&<)> 4054 LEAD IMPLANTED: (B)(6) 2008. 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 THAT THE LEFT VENTRICULAR (LV) LEAD APPEARED TO EXHIBIT LOSS OF CAPTURE. REVIEW OF A REMOTE TRANSMISSION SHOWED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED QUESTION MARKS INSTEAD OF THE VALUE THAT THRESHOLD VOLTAGE HAD INCREASED. THE LEAD REMAINS IN USE, AND THE CRT-D WAS LATER REPLACED DUE TO NORMAL BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539418 ATTAIN PERFORMA MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MPRI 429888 00643169601833

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male DTMA1Q1 CRT-D, 5867-3M LEAD CAP