BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 15048460 · Received July 18, 2022

    Report

    Report Number
    2017865-2022-15404
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    June 27, 2022
    Report Date
    July 18, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. REVIEW OF THE STERILIZATION RECORDS CONFIRMED NORMAL STERILIZATION CYCLES FOR THE PRODUCTS. THE CAUSE OF INFECTION COULD NOT BE DETERMINED. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED AND TRENDED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-15405; RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-15406. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH SKIN EROSION AND INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PACEMAKER, RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR WERE EXPLANTED DUE TO INFECTION. THE PATIENT EXPERIENCED NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240439 ASSURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 P000137281 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention