BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 3863374 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01680
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN MADE A GENERAL OBSERVATION THAT THE INCISION TOOL WAS NOT SHARP ENOUGH, AND REQUIRED MULTIPLE ATTEMPTS TO MAKE A PUNCTURE IN THE SKIN IN ORDER TO DELIVER THE IMPLANTABLE CARDIAC MONITOR. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339034 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1