BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC IPG

    MDR report key: 17521966 · Received August 12, 2023

    Report

    Report Number
    MW5128914
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    June 9, 2017
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LWP
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC NEUROMODULATION (BSN) RECEIVED INFORMATION ABOUT AN EVENT ON (B)(6) 2017 THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. THE INFORMATION RECEIVED STATED THAT THE PATIENT'S MEDTRONIC IPG STOPPED WORKING AND THE PATIENT WOULD UNDERGO A REPLACEMENT PROCEDURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219401 MEDTRONIC IPG IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown