BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 9178362 · Received October 11, 2019

    Report

    Report Number
    1000165971-2019-00571
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    September 10, 2019
    Report Date
    December 27, 2019
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    DXY
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED THE PERMANENT PACING AT MAXIMUM RATE, WHICH WAS INDUCED BY A PARAMETER CORRUPTION DUE TO A SEU (SINGLE EVENT UPSET).

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT. - ATTACHMENT: [20191218 - FILE-2019-03330 - ANALYSIS_AND_CLOSURE_REPORT_RESP-2019-01773.PDF].

    Description of Event or Problem · 0

    REPORTEDLY, A PACEMAKER REPLACEMENT WAS SCHEDULED DUE TO BATTERY DEPLETION. THE DEVICE WAS PROGRAMMED IN VVI MODE, BASIC RATE AT 60BPM AND MAX RATE AT 100BPM. THE ECG REVEALED VENTRICULAR PACING AT MAXIMUM RATE; THE PATIENT WAS BREATHLESS. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED EVENT AND REVEALED THAT THE DEVICE WAS PACING PERMANENTLY AT 130BPM SINCE THE BEGINNING OF JUNE 2019.

    Description of Event or Problem · 0

    REPORTEDLY, A PACEMAKER REPLACEMENT WAS SCHEDULED DUE TO BATTERY DEPLETION. THE DEVICE WAS PROGRAMMED IN VVI MODE, BASIC RATE AT 60BPM AND MAX RATE AT 100BPM. THE ECG REVEALED VENTRICULAR PACING AT MAXIMUM RATE; THE PATIENT WAS BREATHLESS. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED EVENT AND REVEALED THAT THE DEVICE WAS PACING PERMANENTLY AT 130BPM SINCE THE BEGINNING OF JUNE 2019.

    Description of Event or Problem · 1

    REPORTEDLY, A PACEMAKER REPLACEMENT WAS SCHEDULED DUE TO BATTERY DEPLETION. THE DEVICE WAS PROGRAMMED IN VVI MODE, BASIC RATE AT 60BPM AND MAX RATE AT 100BPM. THE ECG REVEALED VENTRICULAR PACING AT MAXIMUM RATE; THE PATIENT WAS BREATHLESS. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED EVENT AND REVEALED THAT THE DEVICE WAS PACING PERMANENTLY AT 130BPM SINCE THE BEGINNING OF JUNE 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972002 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention