BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-S 75-BP

    MDR report key: 1850127 · Received September 21, 2010

    Report

    Report Number
    1028232-2010-01927
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    PER (B)(4) ADVERSE EVENT REPORT, THE LV LEAD WAS FOUND TO BE DISLODGED. AN ATTEMPT TO REVISE THE LEAD ON (B)(6)2010 WAS UNSUCCESSFUL AS THE PT HAD HEMOPNEUMOTHORAX. ALL REPORTS INDICATE THAT THE LEAD REMAINS IMPLANTED. THE PT IS CURRENTLY IN THE HOSPITAL. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. AMD ON (B)(6)2010 - PER REP, LEAD AND DEVICE WERE REMOVED DUE TO PHYSICIAN PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW-S 75-BP LV LEAD NKE BIOSENSE WEBSTER, INC. (JUAREZ) 355148

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization