BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 10830465 · Received November 12, 2020

    Report

    Report Number
    2017865-2020-17652
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 12, 2020
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    RELATED MANUFACTURER REFERENCE NUMBER:2017865-2020-17654, RELATED MANUFACTURER REFERENCE NUMBER:2017865-2020-17655. IT WAS REPORTED THAT THE INCISION SITE WAS INFECTED AND THE PHYSICIAN DECIDED TO REMOVE THE DEVICE AND THE LEADS AFTER SEEING THE INCISION SITE. THE PACEMAKER, ATRIAL LEAD, AND RIGHT VENTRICLE LEAD WERE ALL EXPLANTED. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293270 ASSURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 A000097623 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention TENDRIL STS| TENDRIL STS