BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL LINQ

    MDR report key: 7476862 · Received May 1, 2018

    Report

    Report Number
    2182208-2018-00814
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    June 15, 2017
    Report Date
    May 1, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. WITHOUT THE SPECIFIC MODEL NUMBER(S), IT IS NOT POSSIBLE TO ASSURE THE SPECIFIC PRODUCT CORRECTION NUMBER REFERENCED IN THE ARTICLE IS LISTED IN THIS REPORT. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: DETECTION OF SUBCLINICAL ATRIAL FIBRILLATION IN HIGH-RISK PATIENTS USING AN INSERTABLE CARDIAC MONITOR. JACC: CLINICAL ELECTROPHYSIOLOGY. 2017; 3(13):1557-1564. DOI: 10.1016/J.JACEP.2017.06.020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIAC MONITORS (ICM). THE STUDY SOUGHT TO DETERMINE THE INCIDENCE OF SUBCLINICAL ATRIAL FIBRILLATION (AF) IN HIGH-RISK PATIENTS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT ONE PATIENT REQUIRED REIMPLANTATION OF THE ICM DUE TO A MINOR POCKET INFECTION. THE STATUS OF THE ICM IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320177 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention