BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 22948901 · Received September 2, 2025

    Report

    Report Number
    2017865-2025-99166
    Event Type
    Injury
    Date Received
    September 2, 2025
    Report Date
    October 17, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTION STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES. REVIEW OF THE STERILIZATION RECORDS CONFIRMED NORMAL STERILIZATION CYCLES FOR THE PRODUCTS. THE PRODUCT WAS RETURNED AND VISUAL INSPECTION WAS NORMAL. INTERROGATION OF THE DEVICE REVEALED IT WAS ABOVE ELECTIVE REPLACEMENT INDICATOR (ERI) WHEN RECEIVED. THE CAUSE OF INFECTION COULD NOT BE TRACED TO THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE STERILIZATION RECORDS WERE REVIEWED AND NO EVIDENCE OF ABNORMAL STERILIZATION CYCLE WAS FOUND. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION G3 ¿ THE AWARENESS DATE FOR MDR-2025-38440-02 SHOULD HAVE BEEN 24 SEP 2025 RATHER THAN 25 SEP 2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH ANTIBIOTIC REFRACTORY STAPH INFECTION AND SEPSIS. THE VEGETATION WAS NOTED VIA ECHOCARDIOGRAM ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. THE PACEMAKER AND LEADS WERE EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS STABLE THROUGHOUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH ANTIBIOTIC REFRACTORY STAPH INFECTION. THE VEGETATION WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. THE PACEMAKER AND LEADS WERE EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474038 ASSURITY MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 A000153609 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention