BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 23241474 · Received October 8, 2025

    Report

    Report Number
    2017865-2025-1002189
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 23, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED DUE TO ADVISORY WITH NO ALLEGATION OF A MALFUNCTION. VISUAL INSPECTION OF THE DEVICE AND HEADER ATTACHMENT AREA DID NOT FIND ANY ANOMALIES. INTERROGATION OF THE DEVICE INDICATED BATTERY VOLTAGE AND CURRENT WITHIN NORMAL RANGE WHEN RECEIVED. BASED ON THIS INFORMATION, THE DEVICE WAS FOUND TO COMMUNICATE APPROPRIATELY WITH A MERLIN PROGRAMMER AND HAS NOT REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI).

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2025-1002190 AND 2017865-2025-1002191. IT WAS REPORTED THAT A BRADYCARDIC PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BOTH THEIR RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS FAILING TO CAPTURE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PACEMAKER WAS SUBJECT TO THE ASSURITY AND ENDURITY PACEMAKERS' HEADER ANOMALY ADVISORY ISSUED BY ABBOTT ON 15 MARCH 2021. THE PACEMAKER AND BOTH LEADS WERE EXPLANTED AND REPLACED. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481312 ASSURITY MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 A000082367

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention