BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-S 75-BP

    MDR report key: 6383789 · Received March 7, 2017

    Report

    Report Number
    1028232-2017-00664
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 20, 2017
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OJX
    PMA / PMN Number
    P070008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS LEAD HAD IMPEDANCES OF GREATER THAN 3000 OMHS. PACING VECTOR CHANGED AND IMPEDANCE WAS THEN STABLE. NOISE WAS NOTED AND LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166602 COROX OTW-S 75-BP LV LEAD OJX BIOTRONIK SE & CO. KG 355148

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization