BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEIR DUAL-CHAMBER LEADLESS I2I INVESTIGATIONAL DEVICE EXEMPTION

    MDR report key: 18101231 · Received November 8, 2023

    Report

    Report Number
    MW5147970
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    October 7, 2023
    Report Date
    November 1, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE ABOVE DATE REFLECTS THE LATEST INCIDENT. ON (B)(6) SUFFERING FROM BRADYCARDIA, I ENROLLED IN A CLINICAL STUDY "AVEIR DUAL-CHAMBER LEADLESS I2I IDE(INVESTIGATIONAL DEVICE EXEMPTION) STUDY (IRB(INSTITUTIONAL REVIEW BOARD) PROTOCOL # (B)(4))". AND WAS IMPLANTED WITH THE DEVICES ON (B)(6) 2022, AT (B)(6) HOSPITAL. IT HIS MY UNDERSTANDING THE DEVICES WERE SUBSEQUENTLY, THE DEVICES APPROVED BY THE FDA ON FEBRUARY 2022. SINCE BEING IMPLANTED, THE DEVICES HAVE PROVED TO BE A CONSTANT SOURCE OF PROBLEMS. AND I HAVE RETURNED TO (B)(6) ON AT LEAST SEVEN OCCASIONS, AS RESULT OF CHEST PAINS, BREATHLESSNESS, AND TACHYCARDIA. FOLLOWING ONLY VERY MINIMAL EXERTION (E.G., GOING A FLIGHT OF THIRTEEN STAIRS). EACH TIME I RETURNED, ADJUSTMENTS WERE MADE. AND THEN THE SAME SYMPTOMS ONCE AGAIN RETURNED. ON (B)(6) I SUFFERED AN EPISODE OF SYNCOPE AND WAS BROUGHT TO THE LOCAL HOSPITAL WERE IT WAS NOTED, I EXPERIENCED SEVERAL EXTENDED EPISODES OF "SEVERE" BRADYCARDIA (I.E. BP IN THE THIRTIES). I WAS TRANSFERRED TO (B)(6) WERE I WAS KEPT FOR AN ADDITIONAL (B)(6) DAYS. AND HAD MY PACEMAKERS ADJUSTED ONCE AGAIN. ALAS, AFTER DISCHARGE, THE SYMPTOMS OF CHEST PAIN, BREATHLESSNESS, AND TACHYCARDIA HAVE AGAIN RETURNED. REFERENCE REPORT: .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876584 AVEIR DUAL-CHAMBER LEADLESS I2I INVESTIGATIONAL DEVICE EXEMPTION LEADLESS PACEMAKER PNJ ABBOTT MEDICAL LSP201B

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization| O| S ACYCLOVIR| ASPIRIN 82 MG| GABAPENTIN| LEVOTHYROXINE| LISINOPRIL| MAGNESIUM OXIDE| PANTOPRAZOLE| POMALIDOMIDE| PYRIDOSTIGMINE| VITAMIN B100| VITAMIN D3