BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELOX EX 60-BP

    MDR report key: 24338910 · Received February 13, 2026

    Report

    Report Number
    1028232-2026-00779
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    December 3, 2025
    Report Date
    February 13, 2026
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DBT
    PMA / PMN Number
    K994240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS DELIVERED TO HOSPITAL WITH SYNCOPE DUE TO LOSS OF CAPTURE. A NON-CAPTURE EVENT WAS OBSERVED IN THE PAST, AFTER A GENERATOR CHANGE. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391320 ELOX EX 60-BP PACING LEAD DBT BIOTRONIK SE & CO. KG 330133

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization