BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-L 85-BP

    MDR report key: 4892654 · Received July 6, 2015

    Report

    Report Number
    1028232-2015-02353
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    August 25, 2014
    Report Date
    June 22, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OJX
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    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 RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED AND CRT THERAPY WAS TURNED OFF DUE TO HIGH THRESHOLDS. THERE WERE NO ADVERSE PATIENT SIDE EFFECTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437284 COROX OTW-L 85-BP LV LEAD OJX BIOTRONIK SE & CO. KG 368346

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization