BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX PROMRI OTW 85-BP

    MDR report key: 3891471 · Received June 24, 2014

    Report

    Report Number
    1028232-2014-002121
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OJX
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF 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. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - THIS LV LEAD WAS REPLACED FOR NON-CAPTURE DUE TO DISLODGEMENT. IT WAS REPLACED WITH ANOTHER LV LEAD. THIS LEAD WAS EXPLANTED, BUT NO EXPLANT DATE WAS PROVIDED. IT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369339 COROX PROMRI OTW 85-BP LV LEAD OJX BIOTRONIK SE & CO. KG 381488

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization