BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 25023638 · Received April 28, 2026

    Report

    Report Number
    2124215-2026-23061
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    April 15, 2016
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WILL BE UPDATED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER FELT UNWELL WITH BREATHLESSNESS ON EXERTION AND PRESENTED TO THE HOSPITAL FOR EVALUATION. THE DEVICE WAS NOT INTERROGATED; BASED ON THE PATIENT'S SYMPTOMS, IMPLANT DURATION, AND THE DEVICE'S PACING FUNCTION OBSERVED ON A SURFACE ELECTROCARDIOGRAM (PER HER MEDICAL DEVICE ID CARD, MODEL J067), THE LOCAL REPRESENTATIVE RECOMMENDED IMMEDIATE REPLACEMENT OF THE PACEMAKER. THIS PROCEDURE WAS SCHEDULED FOR (B)(6) 2026. THE PATIENT WAS ADMITTED TO THE HOSPITAL TWO DAYS LATER FOR THE REPLACEMENT SURGERY AND HAD BEEN STARTED ON INTRAVENOUS (IV) ANTIBIOTICS. HOWEVER, DURING THE PRE-OPERATIVE DEVICE INTERROGATION, THE PHYSICIAN DETERMINED THAT THE DEVICE LISTED ON THE PATIENT'S ID CARD DID NOT MATCH THE IMPLANTED DEVICE. ADDITIONALLY, THE MODEL LISTED ON THE ID CARD WAS INCLUDED IN A PRODUCT ADVISORY WHILE THE IMPLANTED DEVICE WAS NOT. INTERROGATION OF THE DEVICE SHOWED A REMAINING LONGEVITY OF ABOUT 2 YEARS AND THEREFORE THE PROCEDURE WAS CANCELLED. IT WAS NOTED THAT DURING THE INITIAL EVALUATION AT THE HOSPITAL, THE PATIENT HAD UNDERGONE AN ECHOCARDIOGRAM THAT REVEALED A JERKY MOTION OF THE SEPTUM AND THEIR LEFT VENTRICLE EJECTION FRACTION (LVEF) WAS 45%. THE PATIENT HAD RECEIVED DIURETICS WHICH IMPROVED THEIR SYMPTOMS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH THE PACEMAKER REMAINING IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE OF BEING UNNECESSARILY ADMITTED TO THE HOSPITAL AND RECEIVING UNNEEDED IV ANTIBIOTICS. THE PATIENT AND THEIR FAMILY WERE ANGRY TO LEARN THAT FOR NEARLY TEN YEARS, THEY WERE CARRYING INCORRECT DEVICE INFORMATION WITH NO KNOWLEDGE OF WHAT HAD ACTUALLY BEEN IMPLANTED, AND WERE CAUSED UNDO ANXIETY AND WORRY WHEN THE PATIENT ALMOST UNDERWENT AN UNNECESSARY SURGERY. A CORRECTED MEDICAL DEVICE ID CARD WAS PROVIDED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551997 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 295644

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other| H