BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANTIO

    MDR report key: 19492923 · Received June 7, 2024

    Report

    Report Number
    2124215-2024-34840
    Event Type
    Death
    Date Received
    June 7, 2024
    Date of Event
    May 9, 2024
    Report Date
    August 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PACEMAKER WAS ANALYZED, AND AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION WAS COMPLETED TO ASSESS THE RATE OF BATTERY DEPLETION. GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE, THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSED ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER HAD PASSED AWAY ON (B)(6) 2024. IT WAS NOTED THAT DURING A PREVIOUS FOLLOW-UP IN JANUARY, THIS PACEMAKER WAS REPORTED TO HAVE EXHIBITED CODE 1003, INDICATIVE OF BATTERY VOLTAGE BEING TOO LOW FOR THE PROJECTED REMAINING CAPACITY. THE PATIENT ADVOCATE ACCUSED THE FOLLOWING PHYSICIAN OF NOT HAVING TAKEN CARE OF THE PATIENT AND THAT THE PACEMAKER'S BATTERY MAY HAVE BEEN PREMATURELY DELETED, THUS LEAVING THE PATIENT WITHOUT CRITICAL THERAPY. DEVICE DATA IS BEING SENT INTO BOSTON SCIENTIFIC FOR FURTHER ANALYSIS. ALL EVIDENCE INDICATES THE PACEMAKER WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER HAD PASSED AWAY ON (B)(6) 2024. IT WAS NOTED THAT DURING A PREVIOUS FOLLOW-UP IN JANUARY, THE BATTERY OF THIS PACEMAKER MAY HAVE BEEN PREMATURELY DEPLETING AND/OR LOWERING TO THE POINT OF REQUIRING A DEVICE REPLACEMENT PROCEDURE. THE PATIENT ADVOCATE ACCUSED THE FOLLOWING PHYSICIAN OF NOT HAVING TAKEN CARE OF THE PATIENT AND THAT THE PACEMAKER'S BATTERY MAY HAVE BEEN PREMATURELY DELETED, THUS LEAVING THE PATIENT WITHOUT CRITICAL THERAPY. ALL EVIDENCE INDICATES THE PACEMAKER WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PLEASE NOTE: THIS PACEMAKER WAS PREVIOUSLY THOUGHT TO HAVE EXHIBITED CODE 1003; HOWEVER, THIS WAS A MISCOMMUNICATION, AND ANALYSIS CONFIRMED THE PACEMAKER DID NOT EVER EXHIBIT CODE 1003 AND REVIEW OF DEVICE MEMORY CONFIRMED THERE WERE NO SUSPICIOUS FAULT OR RESETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012779 ADVANTIO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION J063 158313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death