BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 3812949 · Received May 15, 2014

    Report

    Report Number
    1028232-2014-01553
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OJX
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. DURING THE VISUAL INSPECTION SEVERAL EXPLANTATION DAMAGES WERE NOTED ON THE LEAD. THE CONDUCTOR COILS WERE FOUND DEFORMED AND THE INSULATION WAS DAMAGED AS A RESULT OF LASER EXTRACTION. DURING FURTHER ANALYSIS, NO OTHER DEVIATIONS WERE NOTED. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED BECAUSE THE PHYSICIAN WAS UNHAPPY WITH THE POSITION OF THE LV LEAD. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290328 COROX OTW-S 85-BP LV LEAD OJX BIOTRONIK SE & CO. KG 355149

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization