BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STABILITY QUAD MRI SURESCAN

    MDR report key: 21995563 · Received May 9, 2025

    Report

    Report Number
    2649622-2025-12683
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 16, 2025
    Report Date
    May 9, 2025
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169860421
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0184 LEAD IMPLANTED (B)(6) 2014. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971449 ATTAIN STABILITY QUAD MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MPRI 479888 00643169860421

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| H DTPB2Q1 CRT-D.