BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STABILITY QUAD MRI SURESCAN

    MDR report key: 19014855 · Received April 1, 2024

    Report

    Report Number
    2649622-2024-08789
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 1, 2024
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169860421
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED FROM D10: 1999 LEAD IMPLANTED: (B)(6) 2013. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LEAD. THE LV LEAD 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
    1517477 ATTAIN STABILITY QUAD MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MPRI 479888 00643169860421

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention 6935M55 LEAD, DTPA2QQ CRT-D