BEUDAMED
    FDA Adverse Event Summary report: N

    DEXTRUS 4136

    MDR report key: 3132873 · Received May 29, 2013

    Report

    Report Number
    1028232-2013-01543
    Date Received
    May 29, 2013
    Date of Event
    February 22, 2013
    Report Date
    May 17, 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 ATRIA LEAD WAS DISLODGED INTO THE RIGHT VENTRICLE. IT WAS OBSERVED TO HAVE LOSS OF CAPTURE AND SENSING. THE PATIENT WAS AT THE EMERGENCY ROOM DUE TO PALPITATIONS AND HAD REPORTED COMPLAINTS OF DISCOMFORT AT THE SITE OF THE POCKET. HOWEVER, IT WAS NOTED THAT A PREVIOUSLY CAPPED LEAD WAS UNDERNEATH THE DEVICE AND COULD BE THE CAUSE OF THE DISCOMFORT. THE PHYSICIAN ELECTED TO REPOSITION THIS RA LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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
    234316 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization