BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL LINQ

    MDR report key: 3993689 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01879
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED AND ANALYSIS OF THE DEVICE MEMORY INDICATED RV (RIGHT VENTRICULAR) UNDERSENSING INFORMATION.

    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 IMPLANTABLE CARDIAC MONITOR WAS UNDERSENSING THE PATIENT'S R-WAVES. THE DEVICE HAS BEEN REPROGRAMMED TO THE MOST SENSITIVE SETTING ALONG WITH A DECREASED DECAY DELAY. THE DEVICE REMAINS IN USE AND WILL BE MONITORED POSSIBLY THROUGH MANUAL TRANSMISSIONS SO AS NOT TO HAVE FALSE EPISODES TO REVIEW ALL THE TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467286 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention