BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVEAL DX

    MDR report key: 3620706 · Received February 10, 2014

    Report

    Report Number
    3004209178-2014-02731
    Event Type
    Death
    Date Received
    February 10, 2014
    Date of Event
    October 4, 2013
    Report Date
    January 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE IS NO INFORMATION GIVEN AS TO THE EXACT 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. 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). THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: DEATHS, EROSION, INFECTION, AND DEVICE "MALFUNCTION." INFORMATION OBTAINED THROUGH FOLLOW UP INDICATED THAT THIS PATIENT HAD EXPIRED. THE CAUSE OF DEATH WAS NOTED TO BE BY CARDIOGENIC SHOCK. OF NOTE, THERE WERE NO ARRHYTHMIAS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88412 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9528

    Patients

    Seq Age Sex Outcome Treatment
    1 Death