BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 3992796 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01950
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIAC MONITOR IS "WORKING ITS WAY OUT." THE PATIENT NOTED THAT AT THE IMPLANT PROCEDURE, THE MEDICAL EQUIPMENT COMPANY REPRESENTATIVE SAID THE IMPLANT WAS "PERFECT" AND AT THE FOLLOW-UP APPOINTMENT, THE PHYSICIAN SAID THE INCISION WAS FINE AND AT A SUBSEQUENT WOUND CHECK, THE GENERAL PRACTICE PHYSICIAN SAID IT WAS FINE, HOWEVER THE PATIENT WOKE TO A "TUGGING FEELING" AND FELT THAT THE FIRST FEW LAYERS OF SKIN HAVE BEGUN TO SPLIT. FOLLOW-UP WAS ATTEMPTED WITH THE DEVICE CLINIC BUT THE PATIENT IS TRAVELING AND NO ADDITIONAL INFORMATION COULD BE OBTAINED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470813 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR