BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 3745298 · Received April 11, 2014

    Report

    Report Number
    2182208-2014-01059
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    May 21, 2012
    Report Date
    February 21, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. CORRESPONDENCE WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, AND HAS BEEN ADDED TO THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: PROGRAMMING REVEAL XT AF DETECTION SETTINGS FOR DIFFERENT PATIENT POPULATIONS.¿ TAKEN FROM IEEE TRANS BIOMED ENG. 2008.MARCH. 55 (3): 1219-24. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE LOOP RECORDER (ILR). THE ARTICLE DISCUSSES PROGRAMMING DETECTION SETTINGS FOR DIFFERENT PATIENT POPULATIONS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE ILR/SERIAL NUMBERS. MULTIPLE FAILURE MODES WERE REFERENCED IN THE ARTICLE, WITH NO SPECIFIC ILR MODEL INDICATIONS. THE FAILURE MODES WERE NOTED AS: NOISE, AND "FALSE POSITIVE ATRIAL FIBRILLATION (AF) DETECTION." THE ARTICLE PROPOSES RECOMMENDATIONS FOR PROGRAMMING THE ILR. THE STATUS OF THE ILR IS UNKNOWN. ADDITIONAL INFORMATION FROM FOLLOW UP WITH THE AUTHOR INDICATED THAT THE "NOISE" IS "PRIMARILY BECAUSE OF MYOPOTENTIALS DUE TO STRENUOUS MUSCULAR ACTIVITY PERFORMED BY THE PATIENT." THE ILR ITSELF DID NOT GENERATE THE NOISE. THE EXPLANATION OF "FALSE POSITIVES" INDICATED ARE FULLY DISCLOSED THE CLINICAL MANUAL AND NOT DUE TO A DEFECTIVE DEVICE; HOWEVER, ALL FALSE POSITIVES CANNOT BE EXPLAINED. PER THE AUTHOR, "THE REVEAL DEVICE DOES NOT PROVIDE AUTOMATIC THERAPY IN JUST PROVIDES INFORMATION, AND PHYSICIANS CAN EASILY DETERMINE IF AN EPISODE IS FALSE FROM THE STORED ELECTROGRAM." THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224162 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention