BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN PERFORMA MRI SURESCAN

    MDR report key: 20599926 · Received November 4, 2024

    Report

    Report Number
    2649622-2024-29528
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 4, 2024
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169601833
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. CONTINUATION OF D10: 3369-40Q GENERATOR IMPLANTED: (B)(6) 2024. 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 RIGHT ATRIAL (RA) LEAD, LEFT VENTRICULAR (LV) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED DUE COMPETITOR DEVICE WAS ERODING THROUGH THE POCKET. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166968 ATTAIN PERFORMA MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MPRI 429888 00643169601833

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H 5076-52 LEAD, 6947M62 LEAD.