BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEAD

    MDR report key: 17774090 · Received September 18, 2023

    Report

    Report Number
    MW5145840
    Event Type
    Other
    Date Received
    September 18, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    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 LEAD EXPLANTED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO 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
    2061821 LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK SE & CO. KG S60

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown