BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVEAL

    MDR report key: 3486569 · Received November 25, 2013

    Report

    Report Number
    2182208-2013-03166
    Event Type
    Death
    Date Received
    November 25, 2013
    Date of Event
    October 4, 2013
    Report Date
    November 4, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    MXD
    PMA / PMN Number
    1-CARD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. CORRESPONDENCE WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF THE TIME OF THIS REPORT. REVEAL PLUS AND REVEAL DX/XT WERE THE MODELS INVOLVED IN THE ARTICLE. IT WAS NOT DESIGNATED WHICH MODELS HAD THE FAILURES. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE IS NO INFORMATION GIVEN AS TO THE DATE OF DEATH FOR THE PATIENT; THEREFORE, THE DATE OF DEATH INCLUDED IN THIS REPORT IS PURELY AN ESTIMATE. 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: IMPLANTABLE LOOP RECORDER ALLOWS AN ETIOLOGIC DIAGNOSIS IN ONE-THIRD OF PATIENTS - RESULTS OF THE SPANISH REVEAL REGISTRY. CIRC. J. 2013;77(10):2535-2541.(B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE LOOP RECORDER (ILR) MODEL. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE ILR/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: DEATHS, EROSION, INFECTION, AND DEVICE "MALFUNCTION." THE STATUS OF THE ILR IS UNKNOWN. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612127 REVEAL ELECTRODE, PACEMAKER, PERMANENT MXD MEDTRONIC, INC. MDT-ILR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R