BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 3864881 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01484
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 21, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE IMPLANTABLE CARDIAC MONITOR, THE DEVICE CAME OUT OF THE INCISION SITE SLIGHTLY AND THE PHYSICIAN PUSHED IT BACK IN AND USED A SKIN ADHESIVE FOR CLOSURE. THREE WEEKS AFTER THE PROCEDURE THE PATIENT REPORTED THE DEVICE HAD "FELL OUT." THE PATIENT WAS EVALUATED BY THE PHYSICIAN AND THE DEVICE REMAINS OUT OF SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338234 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR