BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2973496 · Received February 15, 2013

    Report

    Report Number
    1028232-2013-00318
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 6, 2013
    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

    WE WERE NOTIFIED THAT THIS DEVICE WAS EXPLANTED AND WE RECEIVED AN ANALYSIS. THE EXPLANT DATE HAS BEEN ADDED TO THIS FILE. UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. DURING THE VISUAL INSPECTION, CUTTINGS IN THE INSULATION WERE FOUND IN THE REGION OF THE SUTURE SLEEVE. FURTHER ANALYSIS OF THE LEAD DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. IT IS REASONABLE TO ASSUME, THAT THE CUTTINGS RESULTED FROM THE EXPLANTATION PROCEDURE. IN SUMMARY, THE LEAD PRESENTED CUTTINGS IN THE INSULATION, WHICH RESULTED PRESUMABLY FROM THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PT WAS EXPERIENCING SOME EXERCISE INTOLERANCE MOST LIKELY DUE TO LOSS OF AV SYNCHRONY. SYSTEM EVAL NOTED THIS ATRIAL LEAD WAS EXHIBITING LOW P-WAVE MEASUREMENTS, LOSS OF CAPTURE AND NO CAPTURE AT MAXIMUM DEVICE OUTPUTS. THE ASSOCIATED DEVICE WAS PROGRAMMED TO VVI 50 SO THE PT WOULD HAVE AV SYNCHRONY. THE PT WAS FEELING BETTER AFTER THE PROGRAMMING CHANGES WERE MADE. THE CALLER STATED A LEAD REVISION MY BE PERFORMED. NO ADVERSE PT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69394 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization