BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 3770130 · Received April 24, 2014

    Report

    Report Number
    1028232-2014-01339
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 11, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND CUT APPROX. 6 CM DISTAL TO THE IS-1 CONNECTOR PIN. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED FOR ANALYSIS. THE DISTAL FRAGMENT INCLUDING THE LEAD TIP WAS NOT RECEIVED FOR ANALYSIS. THE RETURNED LEAD FRAGMENT WAS VISUALLY AND ELECTRICALLY ANALYSED. THE VISUAL INSPECTION REVEALED THAT THE INSULATION WAS, APART FROM THE PRESENT CUT, FREE OF BREACHES. DURING THE ELECTRICAL ANALYSIS, THE DC RESISTANCES OF THE RECEIVED CONDUCTOR FRAGMENT WERE MEASURED. NO PECULIARITIES WERE FOUND. THE MANUFACTURING PROCESS FOR THIS LEAD WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS. IN CONCLUSION, THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4) 2018 - WE WERE NOTIFIED THAT THIS LEAD WAS EXPLANTED. THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT ATRIAL LEAD EXHIBITED HIGH OUT-OF-RANGE PACING LEAD IMPEDANCE MEASUREMENT. THE DEVICE WAS CHECKED AND NOISE WAS ALSO NOTED. THE PATIENT WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249109 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization