BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 23248280 · Received October 8, 2025

    Report

    Report Number
    MW5177079
    Event Type
    Injury
    Date Received
    October 8, 2025
    Report Date
    September 22, 2025
    Manufacturer
    MICROPORT / SORIN CRM SAS
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED DUE TO INFECTION AND EROSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. 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
    2586296 PULSE GENERATOR, PERMANENT, IMPLANTABLE PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MICROPORT / SORIN CRM SAS TPM014J

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown