BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3002064 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00619
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    December 19, 2012
    Report Date
    February 27, 2013
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS PART OF A SYSTEM IMPLANT PROCEDURE. DURING THE POST-IMPLANT CHECK UP, THE LEAD WAS NOTED TO HAVE POOR SENSING MEASUREMENTS BUT THE THRESHOLD WAS STILL GOOD. FURTHERMORE, THIS LEAD WAS OBSERVED TO EXHIBIT DISLODGEMENT AT THE PRE-DISCHARGE CHECK PERFORMED BY THE FIELD REPRESENTATIVE. THIS LEAD WAS THEN REPOSITIONED ACCORDINGLY BY THE PHYSICIAN AND IT RESULTED IN GOOD MEASUREMENTS OF THE LEAD. THE LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS. RECEIVED ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE CONFIRMING THAT THE LEAD RESULTED IN NORMAL MEASUREMENTS AFTER REPOSITIONING WAS DONE. NO REPORTED ALLEGATIONS THAT THE DISLODGMENT OF THE LEADS DID NOT CAUSE A LOSS OF CAPTURE." BASED ON THE REPORTED EVENT, IT IS UNCLEAR IF THIS LEAD IS IMPLANTED OR NOT. NO DATE OF EXPLANT WAS PROVIDED AND THE LEAD WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105390 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization