BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN PERFORMA MRI SURESCAN

    MDR report key: 24698903 · Received March 26, 2026

    Report

    Report Number
    2649622-2026-08456
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    January 21, 2024
    Report Date
    March 26, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    OJX
    UDI-DI
    00643169601826
    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

    H11: THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION RELATED TO CAPA 711948. CONTINUATION OF D10: 350 973 LEAD IMPLANTED: (B)(6) 2013, 350 974 LEAD IMPLANTED: (B)(6) 2013, W4TR01 CRTP IMPLANTED: (B)(6) 2023, TYRX-AAE IMPLANTED: (B)(6) 2023 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 APPROXIMATELY ONE MONTH POST IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT PRESENTED WITH AN INFECTION. THE CRTP SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760106 ATTAIN PERFORMA MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MEDTRONIC PUERTO RICO VILLALBA 429878 00643169601826

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| H "SEE H11...."