BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURITY MRI

    MDR report key: 23306935 · Received October 15, 2025

    Report

    Report Number
    2017865-2025-1002768
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 27, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON REVIEW THE LOW VOLTAGE DEVICE MANUFACTURER REPORT 2017865-2025-1002768 SHOULD NOT HAVE BEEN SUBMITTED AS MEDICAL DEVICE REPORT (MDR) AS THE NEW INFORMATION RECEIVED THAT ALLEGATION OF MALFUNCTION WAS ON THE RIGHT VENTRICLE LEAD ONLY AND NO ALLEGATION ON THE PACEMAKER.

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS REQUESTED BUT NOT YET RECEIVED.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED THAT THE RIGHT VENTRICULAR (RV) LEAD NOISE WAS OVER SENSED AND HAD LED TO PACING INHIBITION. THE PACEMAKER INDICATED NOISE REVERSION EPISODES WITH NO ALLEGATION OF MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PACEMAKER (PM) HAD NOISE REVERSION EPISODES. ADDITIONALLY, THE RIGHT VENTRICLE (RV) LEAD EXHIBITED NOISE. NO INTERVENTION OR PROCEDURE WERE REPORTED. THE PATIENT HAD NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375873 ASSURITY MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 P000145006 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male 1999 OPTSENSE OPTIM.