BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 3070476 · Received April 22, 2013

    Report

    Report Number
    1028232-2013-01085
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 9, 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 DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS RIGHT ATRIAL LEAD EXHIBITED NO CAPTURE AND NO SENSING. X-RAY IMAGING REVEALED THAT THE LEAD HAD DISLODGED AND WAS HANGING DOWN INTO THE INFERIOR VENA CAVA. THE IMPLANTED DEVICE WAS PROGRAMMED TO VENTRICULAR ONLY PACING THERAPY AND THE PATIENT WAS PLACED IN COMFORT CARE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. AVAILABLE INFORMATION INDICATES THAT THIS LEAD REMAINS IMPLANTED. 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
    172449 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other