BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY MRI

    MDR report key: 23294251 · Received October 15, 2025

    Report

    Report Number
    2017865-2025-1002674
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509602
    PMA / PMN Number
    P140033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS TO RETRACT REPORT 2017865-2025-1002674 SUBMITTED ON 14 OCT 2025. THIS REPORT WAS ERRONEOUSLY SUBMITTED. THIS IS NOT A REPORTABLE EVENT. ALL PREVIOUSLY SUBMITTED INFORMATION SHOULD BE CORRECTED TO NOT APPLICABLE AND NULL FIELDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEMO PACEMAKER WAS UNABLE TO INTERROGATE. FURTHER INFORMATION WAS REQUESTED, HOWEVER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535932 ENDURITY MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2172 A000051427 05414734509602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown