BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL LINQ

    MDR report key: 4160179 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02389
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 9, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 ONE MONTH POST IMPLANT THE IMPLANTABLE CARDIAC MONITOR (ICM) PROTRUDED THROUGH THE WOUND AND THE PATIENT REMOVED THE DEVICE COMPLETELY. THE PHYSICIAN BELIEVED THE ICM MAY HAVE BEEN PLACED SUPERFICIALLY IN THE BREAST TISSUE AT AN ANGLE THAT WHEN COMPRESSED MAY HAVE EXERTED TOO MUCH FORCE ON THE EDGE OF THE WOUND. A NEW DEVICE WAS SUBSEQUENTLY IMPLANTED IN A SLIGHTLY DIFFERENT LOCATION AND WAS SUTURED DOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637689 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R