BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 2203451 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04098
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECORDER HAS BEEN DETECTING ASYSTOLE EVENTS THAT ARE NOT TRUE ASYSTOLE EVENTS DUE TO UNDERSENSING. THE DEVICE 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
    1 REVEAL DX IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other