BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-L 75-BP

    MDR report key: 2933078 · Received January 23, 2013

    Report

    Report Number
    1028232-2013-00081
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    9070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. DURING ANALYSIS THE INNER COILS WERE FOUND DEFORMED. FURTHER INSPECTION SHOWED SLIGHT DAMAGES AT THE INSULATION BECAUSE OF LASER EXTRACTION. IT IS REASONABLE TO ASSUME THAT THESE DAMAGES RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. IN ADDITION, THE DC RESISTANCES WERE INVESTIGATED AND PROVED TO BE FLAWLESS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DIAPHRAGMATIC STIMULATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILL WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33238 COROX OTW-L 75-BP LV LEAD NKE BIOTRONIK SE & CO. KG 368345

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization