BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2952404 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01727
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 11, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T-WAVE OVERSENSING (TWOS) WAS OBSERVED WITH THE IMPLANTABLE CARDIAC MONITOR (ICM) DEVICE FROM A RECENT REMOTE MONITOR REPORT; HOWEVER REAL TIME STRIP LOOKS LIKE NORMAL SENSING. IT WAS ALSO NOTED THAT THERE WERE SOME ASYSTOLE AND VENTRICULAR TACHYCARDIA (VT) AND ATRIAL FIBRILLATION (AF) EPISODES, SOME OF WHICH HAVE ARTIFACT OF OVERSENSING. IT WAS FURTHER REPORTED THAT THE CAUSE OF THE OVERSENSING HAS NOT BEEN DETERMINED AND THE PATIENT IS BEING MONITORED CLOSELY. RECENT TRANSMISSIONS LOOKED GOOD AND FOLLOW UP VISIT SCHEDULED TO SEE IF REDUCING THE SENSITIVITY WILL IMPROVE THE OVERSENSING. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56577 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR