BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 17528344 · Received August 12, 2023

    Report

    Report Number
    MW5135275
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    August 13, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    NVZ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THROUGH A CALL TO TECHNICAL SERVICES ON 6/25/2013 THAT THIS DEVICE WAS EXTRACTED DUE TO INFECTION. THE PHYSICIAN AND FACILITY WERE UNKNOWN. NO OTHER INFORMATION IS AVAILABLE. 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
    763120 PULSE GENERATOR, PERMANENT, IMPLANTABLE PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown