BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 2951445 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01535
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 25, 2012
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THERE WAS INTERFERENCE/NOISE. THE PROGRAMMER SAVE TO DISK FILE (B)(4), SHOWS VARIOUS NOISE IN ELECTROCARDIOGRAM DATA WITH FORTY-TWO FAST VENTRICULAR TACHYCARDIA/VENTRICULAR TACHYCARDIA EPISODES BETWEEN (B)(4) 2012 AND (B)(4) 2012.

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE DEVICE RECORDED AN ADDITIONAL EPISODE THAT APPEARED TO BE FALSE VENTRICULAR TACHYCARDIA EPISODES WHICH SHOWED WANDERING BASELINE WITH ARTIFACT. THE PATIENT HAD NO SYMPTOMS DURING THE EPISODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECORDED EPISODES WHICH APPEARED TO BE NOISE/OVERSENSING AND WERE NOT TRUE VENTRICULAR TACHYCARDIA EPISODES. IT WAS NOTED THAT THE PATIENT WAS NOT SYMPTOMATIC AT THE TIME THE EPISODES WERE RECORDED. THE DEVICE IS STILL 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
    56995 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9528

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR