BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSENTIO MRI DR

    MDR report key: 17021782 · Received May 30, 2023

    Report

    Report Number
    2124215-2023-27226
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    May 11, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. INTERROGATION OF THE DEVICE CONFIRMED IT WAS OPERATING IN SAFETY MODE, AND BRADYCARDIA 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. ALTHOUGH THE OBSERVED RISK (LIKELIHOOD AND SEVERITY) OF THIS BEHAVIOR IS WITHIN THE PRODUCT RISK MANAGEMENT EXPECTATIONS, BOSTON SCIENTIFIC HAS INITIATED A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) INVESTIGATION. REPRESENTATIVES FROM OUR QUALITY ASSURANCE, MANUFACTURING, AND DESIGN ENGINEERING GROUPS ARE ACTIVELY INVESTIGATING THIS BEHAVIOR TO ASSESS POSSIBLE SOLUTION OPPORTUNITIES TO MITIGATE THE POTENTIAL FOR HIGH IMPEDANCE IN THE BATTERY. INFORMATION GAINED THROUGH THESE EFFORTS WILL BE UTILIZED TO IMPLEMENT APPROPRIATE CORRECTIVE ACTION(S), AS NECESSARY.

    Additional Manufacturer Narrative · 0

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER DEVICE WAS FOUND IN SAFETY MODE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED, AND A NEW DEVICE IMPLANTED. BESIDES SURGICAL INTERVENTION, NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS RETURNED, AND ANALYSIS COMPLETED. MKB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER DEVICE WAS FOUND IN SAFETY MODE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED, AND A NEW DEVICE IMPLANTED. BESIDES SURGICAL INTERVENTION, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670052 ESSENTIO MRI DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L111 236536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H