BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRONY II SR+

    MDR report key: 1896606 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05249
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 8, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT, THE R-WAVE AMPLITUDE COULD NOT BE TESTED. IT WAS NOTED THAT THE PATIENT HAD AN INTRINSIC RHYTHM. WHEN RUNNING THE R-WAVE SENSING TEST, THE MESSAGE -INSUFFICIENT INTRINSIC RHYTHM CAN NOT COMPLETE THE TEST- DISPLAYED. THE PACING SYSTEM ANALYZER SHOWED AN R-WAVE AMPLITUDE OF 5.6 MV DURING IMPLANT. DECREASING THE SENSITIVITY TO THE MINIMUM VALUE DID NOT RESOLVE THE ISSUE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRONY II SR+ IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2525T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention