BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3843201 · Received June 2, 2014

    Report

    Report Number
    1028232-2014-01929
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    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

    THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. DURING VISUAL INSPECTION THE RETURNED STYLET WAS FOUND BENT WHAT OCCURRED MOST LIKELY DUE TO MECHANICAL FORCES APPLIED DURING THE SURGERY. FURTHER ANALYSIS REVEALED COAGULATED BLOOD ALONG THE STYLET CAUSING THE INABILITY TO ADVANCE THE STYLET PROPERLY. THESE BLOOD RESIDUALS WERE MOST LIKELY INTRODUCED DURING THE SURGERY. A NEW STYLET INTENDED FOR USE WITH THE LEAD COULD BE PROPERLY INSERTED INTO AND ADVANCED WITHIN THE LEAD¿S LUMEN. FURTHER ANALYSIS OF THE LEAD DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. IN PARTICULAR, THE VALUES OF THE PARAMETERS MEASURED DURING THE MECHANICAL ANALYSIS OF THE FIXATION MECHANISM WERE INVESTIGATED. NO PECULIARITIES WERE FOUND. THE ANALYSIS OF THE RETURNED LEAD DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS DISLODGED. THE PHYSICIAN REMOVED THE LEAD AND IMPLANTED A NEW LEAD AS REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321524 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization