BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY MRI

    MDR report key: 16577490 · Received March 20, 2023

    Report

    Report Number
    2017865-2023-14118
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    March 5, 2023
    Report Date
    June 22, 2023
    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
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H10 - MANUFACTURER NARRATIVE IN MDR-2023-12109-03 SUBMITTED ON 22 JUN 2023 SHOULD HAVE BEEN: THE REPORTED EVENT OF ATRIAL LEAD COULD NOT BE REMOVED FROM THE CONNECTOR WAS CONFIRMED. EPOXY WAS FOUND IN THE CONNECTOR BLOCK THREADS, WHICH RESULTED IN THE INABILITY TO LOOSEN THE SETSCREW. THE OBSERVED EPOXY WAS CAUSED BY A MANUFACTURING ANOMALY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF ATRIAL LEAD COULD NOT BE REMOVED FROM THE CONNECTOR WAS CONFIRMED. EPOXY WAS FOUND IN THE CONNECTOR BLOCK THREADS, WHICH RESULTED IN THE INABILITY TO LOOSEN THE SETSCREW. THE OBSERVED EPOXY WAS CAUSED BY A MANUFACTURING ANOMALY.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO UNSCREW THE RIGHT ATRIAL (RA) LEAD FROM THE HEADER OF THE PACEMAKER. IT WAS NOT SPECIFIED WHETHER THE INABILITY TO REMOVE THE LEAD WAS A PACEMAKER OR LEAD ISSUE. BOTH THE DEVICE AND LEAD WERE ULTIMATELY EXPLANTED AND THE PROCEDURE COMPLETED WITHOUT FURTHER CONSEQUENCES. THE PATIENT WAS IN STABLE CONDITION.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED NOTES THAT THE REPLACEMENT PACEMAKER AND RIGHT ATRIAL LEAD WERE IMPLANTED LATER ON (B)(6) 2023.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-14119, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-19316. NEW INFORMATION RECEIVED THAT THE PATIENT ORIGINALLY PRESENTED IN CLINIC INITIALLY WITH SYNCOPE REPORTED. FLUOROSCOPY WAS PERFORMED AND REVEALED RIGHT VENTRICULAR (RV) LEAD DISLODGEMENT. THE RV LEAD WAS EXPLANTED. THE REPLACEMENT RV LEAD WAS IMPLANTED LATER ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355106 ENDURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2172 P000150028 05414734509602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown