BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3012993 · Received February 26, 2013

    Report

    Report Number
    1028232-2013-00407
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    December 23, 2012
    Report Date
    February 11, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVE INFO THAT THE PATIENT HAD FALLEN APPROX. ONE MONTH PRIOR TO THE DEVICE INTERROGATION. DURING THE DEVICE CHECK THE PATIENT NOTED THAT HE HAD NOT BEEN FEELING WELL. UPON INTERROGATION THE RIGHT ATRIAL LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS WITH NOISE AND HIGH THRESHOLD MEASUREMENTS OF 5 VOLTS AT 0.2MS. THESE ISSUES WERE REPRODUCIBLE IN-CLINIC. A FRACTURE IS SUSPECTED. THE PHYSICIAN PLANS TO REPLACE THE LEAD. HOWEVER, A REVISION PROCEDURE HAS NOT YET BEEN SCHEDULED. NO ADD¿L MEASUREMENTS WERE PROVIDED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83160 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other