BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STABILITY QUAD MRI SURESCAN

    MDR report key: 25335123 · Received May 29, 2026

    Report

    Report Number
    2649622-2026-16012
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    OJX
    UDI-DI
    00643169860421
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0185 LEAD; IMPLANT DATE: (B)(6) 2007. 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 BY THE PATIENT¿S FAMILY MEMBER THAT THE PATIENT WAS FEELING ¿THUMPS¿ FROM THEIR NEWLY IMPLANTED DEVICE. FOLLOW UP CONDUCTED WITH THE CLINIC CONFIRMED THAT THE PATIENT HAD A DEVICE CHECK AND THE THUMPING SENSATION WAS DUE TO PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LV WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196506 ATTAIN STABILITY QUAD MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MEDTRONIC PUERTO RICO VILLALBA 479888 00643169860421

    Patients

    Seq Age Sex Outcome Treatment
    1