BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL LINQ

    MDR report key: 10605680 · Received September 30, 2020

    Report

    Report Number
    2182208-2020-02171
    Event Type
    Injury
    Date Received
    September 30, 2020
    Date of Event
    January 1, 2020
    Report Date
    September 30, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 PRODUCT SERIAL NUMBERS. 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. THE BASELINE AGE OF THE PATIENTS REFERENCED IN THE ARTICLE IS 6 YEARS OLD. REFERENCED ARTICLE: ¿PLACEMENT OF REVEAL LINQ DEVICE IN THE LEFT ANTERIOR AXILLARY POSITION.¿ PEDIATRIC CARDIOLOGY. 2020; 41(1):181-185. DOI: 10.1007/S00246-019-02242-9. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE LOOP RECORDERS (ILRS). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS WITH THE AVAILABLE INFORMATION PROVIDED. THE AUTHOR REPORTED THAT THERE WAS ONE PATIENT WHO HAD THEIR DEVICE EXPLANTED DUE TO A ¿POSSIBLE INFECTION.¿ THE STATUS/DISPOSITION OF THE ILR 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
    1075369 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention