BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2525T MICRONY II, SR+, PKGD/STER

    MDR report key: 11625500 · Received April 6, 2021

    Report

    Report Number
    2017865-2021-12893
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Report Date
    April 6, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWO
    UDI-DI
    05414734006224
    PMA / PMN Number
    P970013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    IT WAS REPORTED THAT A PATIENT'S PACEMAKER PRESENTED WITH AN INAPPROPRIATE RATE INCREASE. TECHNICAL SERVICES NOTED THAT THE TIMING CYCLES WERE PREMATURE VENTRICULAR CONTRACTIONS THAT THE HOLTER ANNOTATED AS PACED DUE TO THEIR SIZE AND MORPHOLOGY. THE HYSTERESIS RATE PICKED UP ON THE DEVICE SO THE RHYTHM WOULD MAKE SENSE WITHOUT ANY ISSUES. NO CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514507 2525T MICRONY II, SR+, PKGD/STER IMPLANTABLE PACEMAKER PULSE GENERATOR LWO ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2525T 2884629 05414734006224

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR