BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 3992452 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01977
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS INTERROGATED WITH NO ISSUES PRIOR TO DEVICE INSERTION. AFTER INSERTION INTO THE PATIENT, THERE WAS NO SENSING. NO NOISE COULD BE GENERATED WITH MOVEMENT OF THE DEVICE, POSITIONING OF THE PATIENT OR PRESSING ON THE RF HEAD. THE DEVICE WAS REMOVED AND ANOTHER ICM WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472721 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR