BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 10257061 · Received July 10, 2020

    Report

    Report Number
    1000165971-2020-00499
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 8, 2020
    Report Date
    October 19, 2020
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS REVEALED THAT THE SUBJECT PACEMAKER SWITCHED IN STANDBY MODE DUE TO THE DETECTION OF CORRUPTED DATA IN THE DEVICE MEMORY. THE CORRUPTION MOST PROBABLY RESULTED FROM A SINGLE EVENT UPSET (SEU). THE DEVICE WAS PROPERLY RE-INITIALIZED DURING THE FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 0

    REPORTEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIZZINESS. THE PACEMAKER WAS FOUND OPERATING IN STANDBY MODE. AFTER IT WAS REINITIALIZED, THE SENSITIVITY PARAMETERS WERE REPROGRAMMED TO AVOID VENTRICULAR OVERSENSING. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED OVERSENSING, WHICH COULD HAVE RESULTED FROM MYOPOTENTIALS AND/OR ELECTROMAGNETIC INTERFERENCES (EMI).

    Description of Event or Problem · 0

    REPORTEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIZZINESS. THE PACEMAKER WAS FOUND OPERATING IN STANDBY MODE. AFTER IT WAS REINITIALIZED, THE SENSITIVITY PARAMETERS WERE REPROGRAMMED TO AVOID VENTRICULAR OVERSENSING. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED OVERSENSING, WHICH COULD HAVE RESULTED FROM MYOPOTENTIALS AND / OR ELECTROMAGNETIC INTERFERENCES (EMI).

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIZZINESS. THE PACEMAKER WAS FOUND OPERATING IN STANDBY MODE. AFTER IT WAS REINITIALIZED, THE SENSITIVITY PARAMETERS WERE REPROGRAMMED TO AVOID VENTRICULAR OVERSENSING. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED OVERSENSING, WHICH COULD HAVE RESULTED FROM MYOPOTENTIALS AND/OR ELECTROMAGNETIC INTERFERENCES (EMI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724435 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY ESPRIT DR 2523

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization