BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2525T MICRONY II, SR+, PKGD/STER

    MDR report key: 11780828 · Received May 5, 2021

    Report

    Report Number
    2017865-2021-17449
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWO
    UDI-DI
    05414734006224
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: 2017865-2021-17448. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR EXPLANT OF THE PULSE GENERATOR AND RIGHT ATRIAL LEAD DUE TO ENDOCARDITIS. THE PATIENT WAS NOT PACEMAKER DEPENDENT AND WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677645 2525T MICRONY II, SR+, PKGD/STER IMPLANTABLE PACEMAKER PULSE GENERATOR LWO ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2525T 0002123288 05414734006224

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention