BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSENTIO DR

    MDR report key: 18966071 · Received March 23, 2024

    Report

    Report Number
    2124215-2024-17635
    Event Type
    Injury
    Date Received
    March 23, 2024
    Date of Event
    March 4, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526558924
    PMA / PMN Number
    N970003/S167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. DEVICE TELEMETRY DATA CONFIRMED IT WAS OPERATING IN SAFETY MODE AND THAT CRITICAL THERAPY REMAINED AVAILABLE. ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH INTERNAL CELL IMPEDANCE WITHIN THE BATTERY. THE HIGH INTERNAL IMPEDANCE PUT THIS DEVICE AT RISK OF EXPERIENCING TRANSIENT VOLTAGE DECREASES (AND ASSOCIATED RESETS) DURING PERIODS OF HIGH-POWER CONSUMPTION. WHEN BATTERY VOLTAGE DROPS BELOW A MINIMUM THRESHOLD, A SYSTEM RESET IS PERFORMED. IF THREE SYSTEM RESETS OCCUR WITHIN A 48-HOUR PERIOD, THE DEVICE IS DESIGNED TO IMMEDIATELY ENTER SAFETY MODE OPERATION TO MAINTAIN BACK-UP PACING WITH PRE-DEFINED, NON-PROGRAMMABLE SETTINGS.

    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 THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER HAD OBSERVED YELLOW COLLECTING WAVES ON THEIR COMMUNICATOR, AND PATIENT-INITIATED INTERROGATION (PII) WERE UNSUCCESSFUL. A FEW DAYS LATER, IT WAS DETERMINED THAT THIS PACEMAKER HAD ENTERED SAFETY MODE. UPON INTERROGATION, THE FOLLOWING CODES WERE NOTED: 0X12 0XF 0XE. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS, RECOMMENDING EMERGENT DEVICE REPLACEMENT AND PRODUCT RETURN FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT IS EXPECTED TO BE RETURNED BY THE EXPLANTING FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER HAD OBSERVED YELLOW COLLECTING WAVES ON THEIR COMMUNICATOR, AND PATIENT-INITIATED INTERROGATION (PII) WERE UNSUCCESSFUL. A FEW DAYS LATER, IT WAS DETERMINED THAT THIS PACEMAKER HAD ENTERED SAFETY MODE. UPON INTERROGATION, THE FOLLOWING CODES WERE NOTED: 0X12 0XF 0XE. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS, RECOMMENDING EMERGENT DEVICE REPLACEMENT AND PRODUCT RETURN FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT IS EXPECTED TO BE RETURNED BY THE EXPLANTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524617 ESSENTIO DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L101 768082 00802526558924

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| R