BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 3990276 · Received August 7, 2014

    Report

    Report Number
    9614453-2014-01799
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 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
    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. PRODUCT EVENT SUMMARY : THE DEVICE WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE IMPLANTABLE CARDIAC MONITOR SHOWED NOISE ON THE ELECTROCARDIOGRAM (ECG) WHEN THE R WAVES WERE CHECKED. A SECOND PROGRAMMER WAS USED TO REVIEW THE ECG, BUT THE NOISE WAS STILL PRESENT. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463736 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1