BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 6008850 · Received October 6, 2016

    Report

    Report Number
    9614453-2016-06253
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 23, 2016
    Report Date
    August 25, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO EMI (ELECTROMAGNETIC INTERFERENCE)/NOISE. NOISE AND OVERSENSING OBSERVED. ASYSTOLE EPISODES WITH APPARENT UNDERSENSING OBSERVED ON ELECTROCARDIOGRAMS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIAC MONITOR (ICM) WAS UNDERSENSING CAUSING FALSE POSITIVES DUE TO INADEQUATE R-WAVES. ADDITIONALLY, THE DEVICE DEMONSTRATED OVERSENSING. SOMETIMES THE DEVICE ONLY SENSES P-WAVES OR NONE AT ALL DUE TO MUSCLE NOISE. THE DEVICE WILL BE RE-POSITIONED. 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
    654273 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR