BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA IPG

    MDR report key: 11601048 · Received April 1, 2021

    Report

    Report Number
    3004209178-2021-05301
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 8, 2021
    Report Date
    April 1, 2021
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    UDI-DI
    00613994222114
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    THE PATIENT REPORTED THEY HAVE BEEN FEELING SHORT OF BREATH AND HAS BEEN BLACKING OUT. IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498880 VERSA IPG PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01 00613994222114

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening 407658 LEAD, 407652 LEAD.