BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 3991214 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02177
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN FEELS THAT THE SCALPEL FOR MAKING THE INITIAL INCISION FOR THE IMPLANTABLE CARDIAC MONITOR CREATES A PUNCTURE THAT IS LARGER AND MORE DIFFICULT TO CLOSE THAN IS NECESSARY. THE TOOL WAS DISCARDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468013 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1