BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2790894 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05513
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 17, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT TO THE EMERGENCY DEPARTMENT WITH SYMPTOMS OF PALPITATIONS. THE PACEMAKER REVEALED INTERVALS OF VENTRICULAR PACED EVENTS DRIVING THE ATRIUM. THE DEVICE WAS REPROGRAMMED TO AN ATRIAL ONLY MODE AND REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 3830 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD