BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-L 85-BP

    MDR report key: 8701340 · Received June 14, 2019

    Report

    Report Number
    1028232-2019-02463
    Event Type
    Injury
    Date Received
    June 14, 2019
    Report Date
    June 13, 2019
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OJX
    UDI-DI
    04035479112172
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    DEVICE COULD NOT INTERROGATE IN CLINIC. REP DETERMINED THAT THE DEVICE WAS NOT A BIOTRONIK DEVICE AND ALL LEADS HAD BEEN EXPLANTED FOR A LEADLESS PACEMAKER. PER THE PATIENTS DAUGHTER, THIS DEVICE WAS EXPLANTED IN (B)(6) 2018 DUE TO INFECTION. EXPLANT DATE AND LOCATION IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492516 COROX OTW-L 85-BP LV LEAD OJX BIOTRONIK SE & CO. KG 368346 04035479112172

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization