BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW 75-UP STEROID

    MDR report key: 2992878 · Received March 1, 2013

    Report

    Report Number
    1028232-2013-00570
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED AND REPLACED DUE TO DISLODGEMENT. IT IS SUSPECTED THAT THE LEAD PULLED BACK A "COUPLE YEARS AGO". THE PHYSICIAN PROGRAMED THE DEVICE ACCORDINGLY AND WAITED UNTIL THE DEVICE WAS AT ERI TO CAP THIS LEAD AND REPLACED IT. THERE WERE NO ADVERSE PT EVENTS REPORTED. SHOULD ADDITIONAL INFO BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89359 COROX OTW 75-UP STEROID LV LEAD NKE BIOTRONIK SE & CO. KG 346542

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization