BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 8623550 · Received May 20, 2019

    Report

    Report Number
    2182208-2019-00927
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    January 1, 1999
    Report Date
    May 20, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A ¿PROBLEM¿ WITH THEIR IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT STATED THIS HAPPENED APPROXIMATELY TWENTY YEARS AGO. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416890 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1