BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 23164074 · Received September 28, 2025

    Report

    Report Number
    2017865-2025-1001460
    Event Type
    Injury
    Date Received
    September 28, 2025
    Report Date
    October 27, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D6B EXPLANT DATE SHOULD NOT HAVE BEEN UPDATED "(B)(6) 2025" IN THE INITIAL REPORT 2017865-2025-1001460. THE PACEMAKER WAS NOT EXPLANTED INSTEAD REMAINED IMPLANTED AS TEMPORARY PACEMAKER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS PRESENTED TO THE HOSPITAL WITH A POCKET EROSION. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED VIA A NON-LASER EXPLANT PROCEDURE WITH GENTLE TRACTION. THE EXISTING PACEMAKER AND NEW RV LEAD WAS USED AS A TEMP-PERM DEVICE. NO PATIENT SYMPTOM WAS REPORTED.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT WAS PRESENTED AT THE HOSPITAL DUE TO INFECTION AND POCKET EROSION. THE PATIENT'S PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD WERE REVISED DUE TO AN INFECTION CAUSED BY METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) AND OPERATIVE CULTURES GREW CORYNEBACTERIUM. THE PACEMAKER WAS NOTED TO BE ERODED THROUGH THE SKIN AND IT WAS UNCLEAR WHEN THE POCKET EROSION STARTED. THE POCKET EROSION AND INFECTION WERE NOT RELATED TO AN ABBOTT-PROCEDURE OR ABBOTT-DEVICE. THE PATIENT'S RV LEAD WAS EXPLANTED AND REPLACED VIA A NON-LASER EXPLANT PROCEDURE WITH GENTLE TRACTION. THE EXISTING PACEMAKER AND A NEW RV LEAD WAS USED AS A TEMP-PERM DEVICE. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797590 ASSURITY MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM1272 P000190536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 2088TC/58 TENDRIL RIGHT VENTRICULAR LEAD