BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACEMAKER

    MDR report key: 15807126 · Received November 15, 2022

    Report

    Report Number
    MW5113324
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 14, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ABBOTT PACEMAKER MODEL NO: PM2162, SERIAL NO (B)(4), THIS DEVICE IS NOT FUNCTIONING PROPERLY, MAKES NOISE, PATIENT COMPLAINING, DIZZINESS, SLEEPLESSNESSES, LOST OF APPETITE, PAINS AT CHEST SIDE. IMPLANTED DEVICE IDENTITY CARD PATIENT PRESENTLY LIVING IN NIGERIA NAME: (B)(6), PHYSICIAN: DR (B)(6), TEL: (B)(6), HOSPITAL (B)(6), SOUTH AFRICA; IMPLANTED DATE: (B)(6)2016. PATIENT'S SON PHONE CONTACT IN SA: (B)(6) OR CONTACT ME FOR FURTHER INFO ON (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2833011 PACEMAKER IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ABBOTT MEDICAL PM2162

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R| L RALEAD 2088TC2