BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY D

    MDR report key: 22915942 · Received August 28, 2025

    Report

    Report Number
    MW5175361
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 22, 2025
    Product Code
    NLG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPROCESSED PENTARAY PLACED IN PATIENT'S BODY. MAPPING SYSTEM WITH SENSOR ERROR AND UNABLE TO DETECT CATHETER. TRIED REPLACING THE CABLE AND CATHETER STILL WITH SENSOR ERROR. REPLACED CATHETER WITH NEW CATHETER AND ABLE TO DETECT THIS CATHETER WITH SYSTEM. MANUFACTURER NAME, JOHNSON AND JOHNSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130318 PENTARAY D CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY, REPROCESSED NLG D128211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening