BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN PERFORMA S MRI SURESCAN

    MDR report key: 19269416 · Received May 8, 2024

    Report

    Report Number
    2182208-2024-01979
    Event Type
    Death
    Date Received
    May 8, 2024
    Date of Event
    February 23, 2024
    Report Date
    May 8, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A VOLUNTARY MEDWATCH FORM 3500 WAS RECEIVED (REPORT #MW5153384); SINCE F10 IS NOT CONTAINED ON THAT FORM, SELECT FIELDS IN SECTION F HAVE BEEN POPULATED BY THE MANUFACTURER.  F1 USER FACILITY F2 UF/IMPORTER REPORT NUMBER: F3 USER FACILITY NAME/ADDRESS: F4 CONTACT PERSON: F5 PHONE NUMBER: F6 DATE USER FACILITY BECAME AWARE OF THE EVENT: F7 TYPE OF REPORT: VERSION 0 F8 DATE OF THIS REPORT:  23-FEB-2024 F9 APPROXIMATE AGE OF DEVICE: F10 EVENT PROBLEM CODES: F11 REPORT SENT TO FDA: N F12 LOCATION WHERE EVENT OCCURRED: F13 REPORT SENT TO MANUFACTURER: F14 MANUFACTURER NAME AND ADDRESS: MFR. NAME: MEDTRONIC ADDRESS: 8200 CORAL SEA STREET NE CITY: MOUNDS VIEW STATE: MN ZIP: 55112. 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 THERE WAS A HIGH IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD AND THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100907 ATTAIN PERFORMA S MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MEDTRONIC, INC. 4598

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death