BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 1935170 · Received December 6, 2010

    Report

    Report Number
    1028232-2010-02682
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 26, 2010
    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 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. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 - WE WERE NOTIFIED THAT THIS LEAD WAS RETURNED FOR ANALYSIS WITH NO ADDITIONAL COMPLAINT INFORMATION. THE EXPLANT DATE IS UNKNOWN. UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND DISSECTED APPROX. 5 CM DISTAL TO THE IS-1 CONNECTOR PIN. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE SURGERY. THE RETURNED LEAD FRAGMENT WAS VISUALLY AND ELECTRICALLY ANALYZED. THE VISUAL INSPECTION REVEALED DEFORMATIONS OF THE INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN. TENSILE FORCES DURING THE EXPLANT PROCEDURE SHOULD BE TAKEN INTO CONSIDERATION. DURING THE ELECTRICAL ANALYSIS, THE DC RESISTANCES OF THE RECEIVED CONDUCTOR FRAGMENTS WERE MEASURED. NO PECULIARITIES WERE FOUND. IN SUMMARY, THE LEAD WAS FOUND DISSECTED UPON RECEIPT, WHICH OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS OF THE AVAILABLE LEAD FRAGMENT DID NOT REVEAL ANY INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR RV LEAD EXHIBITED LOSS OF CAPTURE AT MAXIMUM OUTPUTS IN BIPOLAR AND UNIPOLAR PACING CONFIGURATIONS. PREVIOUSLY, THE RV LEAD IMPEDANCE MEASUREMENT WAS 900 OHMS AND HAS RISEN TO 1300 OHMS WITH A LOW R-WAVE AMPLITUDE OF 4.0 MV. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT THE PHYSICIAN IS CONSIDERING A LEAD REVISION; HOWEVER, AT THIS TIME, HE IS UNAWARE OF THE COURSE OF ACTION THAT THE PHYSICIAN WILL CHOOSE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND THE INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other