BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 18252777 · Received December 1, 2023

    Report

    Report Number
    2124215-2023-68275
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 22, 2023
    Report Date
    March 29, 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

    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 THAT BRADYCARDIA THERAPY REMAINED AVAILABLE. SYSTEM RESETS OCCURRED DURING A TELEMETRY SESSION AND WHILE COMMUNICATING WITH THE LATITUDE REMOTE MONITORING SYSTEM AND CAUSED THE DEVICE TO ENTER SAFETY MODE. ENGINEERS DETERMINED THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH INTERNAL CELL IMPEDANCE WITHIN THE BATTERY. THE HIGH INTERNAL IMPEDANCE RESULTED IN THE SYSTEM RESETS DUE TO TEMPORARY HIGH-POWER CONSUMPTION AND SUBSEQUENT REVERSION TO SAFETY MODE OPERATION. BOSTON SCIENTIFIC HAS ISSUED A FIELD SAFETY NOTICE REGARDING INGENIO EXTENDED LIFE (EL) AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES THAT MAY EXHIBIT THIS BEHAVIOR. THIS PARTICULAR DEVICE IS INCLUDED IN THE HIGH IMPEDANCE IN INGENIO EXTENDED LIFE (EL) PACEMAKER AND CRT-P ADVISORY POPULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) SCAN, AFTER WHICH THEIR PACEMAKER RECORDED A CODE 9001, INDICATING A FAULT OCCURRED WHILE THE DEVICE WAS IN MRI PROTECTION MODE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT-OF-RANGE IMPEDANCE, AND A LEAD FRACTURE WAS OBSERVED ON X-RAY IMAGING. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THEIR PACEMAKER WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. THE RA LEAD REMAINS IMPLANTED BUT OUT OF SERVICE. BESIDES INTERVENTION, THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL INFORMATION: THIS PRODUCT WAS RETURNED, AND ANALYSIS WAS COMPLETED. THIS REPORT IS UPDATED WITH THE PRODUCT INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) SCAN, AFTER WHICH THEIR PACEMAKER RECORDED A CODE 9001, INDICATING A FAULT OCCURRED WHILE THE DEVICE WAS IN MRI PROTECTION MODE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT-OF-RANGE IMPEDANCE, AND A LEAD FRACTURE WAS OBSERVED ON X-RAY IMAGING. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THEIR PACEMAKER WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. THE RA LEAD REMAINS IMPLANTED BUT OUT OF SERVICE. BESIDES INTERVENTION, THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED. DEVICE RETURN IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430144 INGENIO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION J177 100682

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Unknown Required Intervention| H