BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSENTIO SR

    MDR report key: 25250438 · Received May 21, 2026

    Report

    Report Number
    2124215-2026-27569
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    June 1, 2014
    Report Date
    May 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LITERATURE REVIEW THAT THERE WAS A RETROSPECTIVE COHORT STUDY THAT TOOK PLACE ANALYZING THE COMPLICATIONS ASSOCIATED WITH BOSTON SCIENTIFIC'S INGENIO AND ACCOLADE PRODUCT LINES AND SAFETY MODE. THE STUDY TOOK PLACE FROM 01-JUNE-2014 TO 01-JANUARY-2025 AND INVOLVED 2,952 PATIENTS ASSOCIATED WITH THE VETERANS AFFAIRS (VA) NATIONAL CARDIAC DEVICE SURVEILLANCE PROGRAM, WHICH INCLUDES DEVICE DATA AND REMOTE MONITORING TRANSMISSIONS FOR ALL PATIENTS WITH PACEMAKERS FOLLOWED BY 121 DEPARTMENT OF VETERANS AFFAIRS DEVICE CLINICS. TO BROADLY IDENTIFY SAFETY MODE INITIATIONS, ALL 2,952 PATIENTS WITH SUCH PACEMAKER FAMILIES ON ADVISORY WERE SCREENED FOR SAFETY MODE INITIATION AT ANY BATTERY LIFE AND WITH ANY LENGTH OF VA FOLLOW-UP. THE STUDY IDENTIFIED SAFETY MODE THROUGH REMOTE MONITORING TRANSMISSIONS, KEYWORD SEARCH OF THE VA ELECTRONIC HEALTH RECORD (EHR) FOR "SAFETY MODE", AND CHART REVIEW OF PATIENTS WHO HAD RECEIVED GENERATOR REPLACEMENTS TO EVALUATE FOR SAFETY MODE INITIATION BEFORE GENERATOR CHANGE. THROUGH VA EHR CHART REVIEW, THE STUDY IDENTIFIED COMPLICATIONS THAT WERE ACUTE ONSET AND CONCURRENT WITH SAFETY MODE INITIATION. A TOTAL OF 47 PATIENT'S HAD SAFETY MODE DECLARED DURING THE STUDY PERIOD. SAFETY MODE WAS IDENTIFIED DURING PACEMAKER INTERROGATION WITHIN A HEALTH CARE SETTING IN NINE PATIENTS, AND VIA REMOTE MONITORING IN THE OTHER 38 PATIENTS. COMPLICATIONS ARISING FROM THE DECLARATION OF SAFETY MODE VARIED, BUT THE SERIOUS PROBLEMS INCLUDED TWO PATIENTS WHO HAD DIED (COVERED IN COMPLAINTS (B)(4) AND (B)(4), EIGHT PATIENTS WHO EXPERIENCED SYNCOPAL EPISODES, THREE PATIENTS WHO EXPERIENCED PRE-SYNCOPAL EPISODES, THREE PATIENTS WHO EXPERIENCED FALLS WITH TRAUMA, AND 11 PATIENTS WHO EXPERIENCED OVERSENSING AND PACING INHIBITION CAUSING ASYSTOLE. OTHER COMMON COMPLICATIONS OBSERVED THROUGHOUT THE STUDY INCLUDED 10 PATIENTS WHO EXPERIENCED DYSPNEA, EIGHT WHO EXPERIENCED DIZZINESS, EIGHT WHO EXPERIENCED FATIGUE, AND SIX WHO EXPERIENCED SOME FORM OF MUSCLE STIMULATION. A TOTAL OF 29 PATIENTS PRESENTED TO THE EMERGENCY DEPARTMENT OF THEIR RESPECTIVE HOSPITAL DUE TO THE DECLARATION OF SAFETY MODE, AND OF THOSE 29, TEN REQUIRED INTENSIVE CARE UNIT ADMISSION. DUE TO THE LARGE NUMBER OF PATIENT'S INVOLVED AND THE LENGTH OF THE STUDY LASTING OVER A DECADE, THE STATUS OF ALL AFFECTED INGENIO AND ACCOLADE DEVICES INVOLVED IN THIS STUDY CANNOT BE DETERMINED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. A GOOD FAITH EFFORT WAS MADE TO CONTACT THE AUTHOR OF THIS LITERATURE ARTICLE IN AN ATTEMPT TO GATHER MORE INFORMATION, PARTICULARLY ANY FURTHER MODEL/SERIAL INFORMATION OF THE PRODUCTS INVOLVED IN THE STUDY. NO RESPONSE WAS PROVIDED AT THIS TIME. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509672 ESSENTIO SR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1