BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW 85-BP

    MDR report key: 2012561 · Received February 28, 2011

    Report

    Report Number
    1028232-2011-00456
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 17, 2011
    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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING 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.

    Additional Manufacturer Narrative · 1

    (B)(4) 2015 - THIS LEAD WAS CAPPED ON (B)(6) 2011. THE FILE REMAINS CLOSED.

    Description of Event or Problem · 1

    THIS LEAD BECAME DISLODGED, BUT WHEN THE PHYSICIAN ATTEMPTED TO EXTRACT THE LEAD, IT WOULD NOT COME OUT. THIS LEAD REMAINS IMPLANTED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW 85-BP LV LEAD OJX BIOTRONIK SE & CO. KG 354807

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization