BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC DF 4LL CARDIOVERTER DEFIBRILLATOR

    MDR report key: 16015481 · Received December 19, 2022

    Report

    Report Number
    MW5113857
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    June 9, 2022
    Report Date
    December 12, 2022
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021 MY HEART DOCTOR INPLANT PACEMAKERS DEFIBRILLATOR AND THE PACK NEVER HEAL RIGHT, SO IT GOT INFECTION. SO THE DOCTOR HAD TO TAKE ALL THAT OUT OF ME, SO MUCH PAINNOW THEY ARE SAYINGTHAT IT WAS A MALFUNCTION OF BIVENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). GENERATOR INITIAL BIOVENTRICULAR (ICD) "CLA-EML" T82 111A. SO THIS IS WHY I'M COMPLAINING ABOUT THIS. I'M NOT HAPPY WITH ALL THE PAIN I HAD PUT WITH. I HAVE ALL OF THE MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858709 BOSTON SCIENTIFIC DF 4LL CARDIOVERTER DEFIBRILLATOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC 1540060673/0022 D022-128511

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Life Threatening LIFE VEST.