BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 3092017 · Received May 3, 2013

    Report

    Report Number
    1028232-2013-01312
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED. ALL PARTS OF THE LEAD WERE RECEIVED. THE MORPHOLOGY OF THE CUTTINGS INDICATES THAT THE FRAGMENTATION OF THE LEAD MOST LIKELY ORIGINATED FROM THE EXPLANT PROCEDURE. THE RETURNED DEVICE WAS VISUALLY AND ELECTRICALLY ANALYSED. THE INSPECTION OF THE INSULATION CONFIRMED THAT THE LEAD WAS, APART FROM THE PRESENT CUTTINGS, FREE OF INSULATION BREACHES. IN ADDITION, THE DC RESISTANCES OF THE CONDUCTOR FRAGMENTS WERE INVESTIGATED AND PROVED TO BE FLAWLESS. NO PECULIARITIES WERE FOUND. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. IN SUMMARY, NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM WAS NOTED DURING ANALYSIS.

    Description of Event or Problem · 1

    THE PHYSICIAN BELIEVED THERE WAS A SENSING ISSUE ON THIS LEAD AND CHOSE TO REPLACE IT WITH A QUADRIPOLAR LV LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194166 COROX OTW-S 85-BP LV LEAD NKE BIOTRONIK SE & CO. KG 355149

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization