BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE PULSE GENERATOR (IPG)

    MDR report key: 20797702 · Received November 26, 2024

    Report

    Report Number
    MW5162940
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Report Date
    November 12, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE WERE INFORMED ON (B)(6) 2024 ABOUT AN EVENT REGARDING A PATIENT WITH MEDTRONIC DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT UNDERWENT A MEDTRONIC IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT WITH A (B)(6) DEVICE DUE TO DIFFICULTY CHARGING. THE PHYSICIAN'S NAME IS DR. (B)(6), KY. PLEASE NOTE THIS IS NOT A DEVICE MANUFACTURED BY (B)(6), AND NO FURTHER DETAILS WERE PROVIDED. 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
    2614538 IMPLANTABLE PULSE GENERATOR (IPG) PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DEEP BRAIN STIMULATION (DBS) SYSTEM.