BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELOX EX 53 BP

    MDR report key: 1032408 · Received April 14, 2008

    Report

    Report Number
    1028232-2008-00354
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    January 28, 2008
    Report Date
    March 11, 2008
    Manufacturer
    BIOTRONIK GMBH ANC CO.
    Product Code
    DTB
    PMA / PMN Number
    K994240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE ANALYSIS IS 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. REVIEW OF THE QUALITY DOCUMENTS SHOWED A REGULAR MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THIS LEAD WAS NOT RETURNED, HOWEVER, BIOTRONIK REPRESENTATIVE BILL MADEIRA RETURNED THE OOS DOCUMENTATION. THIS LEAD HAS AN INSULATION BREAK THAT WAS DISCOVERED DURING A DEVICE UPGRADE. DAMAGE WAS ALSO SEEN AT THE YOKE OF THE VENTRICULAR LEAD. THE LEADS WERE CAPPED AND A NEW SYSTEM WAS IMPLANTED. THIS LEAD WAS REPLACED WITH A SETROX S 53. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PT. THIS LEAD WAS REMOVED WITH A KAINOX SL 75/18, MDR 1028232-2008-00355. BOTH LEADS WERE EXPLANTED DUE TO THE SAME COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization