BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2943811 · Received January 31, 2013

    Report

    Report Number
    1028232-2013-00159
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 18, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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 PRODUCT 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 LEAD EXHIBITED HIGH THRESHOLD. THIS WAS DETERMINED DURING A ROUTINE FOLLOW-UP TO THE PHYSICIAN'S OFFICE. AT THE CATH LAB, THE LEAD WAS REPOSITIONED AND THEN THE THRESHOLD WAS 1.0V AT 0.4MS. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION. ADDITIONAL INFORMATION CONFIRMED THAT THERE WAS NO EVIDENCE OF DISLODGEMENT OR LOSS OF CAPTURE. THE PATIENT WAS NOT PACER DEPENDENT. A REVISION PROCEDURE WAS PERFORMED BUT NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AT THIS TIME. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43135 DEXTRUS 4137 PACER LEAD DTB BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization