BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 2953196 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01911
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    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).

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE REMOTE TRANSMISSION SHOWED SOME OVERSENSED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL ASYSTOLE EPISODES (UNDERSENSING R-WAVES) WERE RECORDED SINCE IMPLANT OF THE LOOP RECORDER. THE PATIENT DENIED ANY SYMPTOMS. THE UNDERSENSING WAS POSSIBLY DUE TO THE NEW IMPLANT POCKET. 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
    55390 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9528

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR