BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 1860900 · Received October 7, 2010

    Report

    Report Number
    6000144-2010-05019
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 19, 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. PATIENT HAD SEVERE CHEST PAINTS COINCIDENT WITH EPISODE #1673. PATIENT WAS CARDIOVERTED. STORED ECG FROM EPISODE #1673 IS NEARLY 'FLAT''. STORED ECG FROM OTHER EPISODES IS 'NORMAL'. NO INFORMATION FROM DEVICE LEADS TO CONCLUDE EITHER SVT (SUPRA VENTRICULAR TACHYCARDIA) OR VT (VENTRICULAR TACHYCARDIA).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD SEVERE CHEST PAINS AND WAS CARDIOVERTED. THE CORRESPONDING STORED ECG DATA IS NEARLY FLAT AND OTHER EPISODE ECG DATA IS NORMAL. 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 XT IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9529 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention