BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL PLUS

    MDR report key: 3744763 · Received April 11, 2014

    Report

    Report Number
    2032545-2014-00005
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    October 4, 2013
    Report Date
    January 16, 2014
    Manufacturer
    ARIZONA DEVICE MFG
    Product Code
    MXC
    PMA / PMN Number
    K994331
    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. THE YEAR IS VALID FOR THE PATIENT¿S DATE OF BIRTH. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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). INFORMATION OBTAINED THROUGH FOLLOW UP INDICATED THAT THERE WAS POSSIBLE UNDERSENSING NOTED. THE STATUS OF THE ILR IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223111 REVEAL PLUS RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION) MXC ARIZONA DEVICE MFG 9526

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention