BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 1991785 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00934
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 27, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING ISSUES WERE NOTED AS THE LIFETIME ASYSTOLE EPISODE COUNTER WAS 551.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, AN IMPLANTABLE LOOP RECORDER, HAD A SENSING ISSUE DUE TO LOSS OF CONTACT WITH TISSUE WITHIN ONE DAY AFTER IMPLANT, CAUSING BOTH A FALSE AUTOMATICALLY-RECORDED ASYSTOLE EPISODE AND CAUSING A MANUALLY-TRIGGERED "SYMPTOM" EPISODE TO BE DIFFICULT TO INTERPRET. THE PATIENT REPORTEDLY HAD A TRUE EPISODE OF PASSING OUT, THE DAY BEFORE THE CHECK. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL XT IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9529 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention