BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-L 75-BP

    MDR report key: 3100777 · Received May 8, 2013

    Report

    Report Number
    1028232-2013-01325
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    February 11, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    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 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

    THE PATIENT HAD LOSS OF CAPTURE ON THE LV LEAD. BIV PACING WAS TURNED OFF FOR NOW AND PATIENT WILL BE OBSERVED. LV LEAD MAY BE REVISED IN THE FUTURE. ON (B)(6) 2013 - WE WERE NOTIFIED THAT THIS LEAD WAS REVISED ON (B)(6) 2013 AND REMAINS ACTIVELY IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT HAD LOSS OF CAPTURE ON THE LV LEAD. BIV PACING WAS TURNED OFF FOR NOW AND PATIENT WILL BE OBSERVED. LV LEAD MAY BE REVISED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200938 COROX OTW-L 75-BP LV LEAD NKE BIOTRONIK SE & CO. KG 368345

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization