BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2964643 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02365
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    July 3, 2012
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: PERFORMANCE DATA REGARDING THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. DATA REVEALED THAT THE DEVICE WAS OVERSENSING.

    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 LOOP REORDER (ILR) WAS OVERSENSING AND NOISE WAS PRESENT. THE ILR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE LOOP REORDER (ILR) WAS OVERSENING AND NOISE WAS PRESENT. THE ILR 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
    67307 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR