BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELOX EX 53-BP

    MDR report key: 1470908 · Received August 24, 2009

    Report

    Report Number
    1028232-2009-01121
    Event Type
    Malfunction
    Date Received
    August 24, 2009
    Date of Event
    November 20, 2008
    Report Date
    July 23, 2009
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    K994240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - THE LEAD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS OF THE LEAD IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE MANUFACTURING PROCESS OF THE LEAD WAS EXAMINED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED TO US THAT OVERSENSING OCCURRED WITH THE ATRIAL LEAD, BUT IT IS UNCLEAR WHAT HAS CAUSED THIS. THE LEAD COULD NOT BE EXPLANTED. THE ICD HAS BEEN RECEIVED FOR ANALYSIS. THE DATE OF IMPLANTATION WAS NOT PROVIDED. BELOS DR-T, MDR 1028232-2009-01014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELOX EX 53-BP PACER LEAD DTB BIOTRONIK SE & CO. KG 130018

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization