BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2483809 · Received March 5, 2012

    Report

    Report Number
    1028232-2012-00501
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    January 9, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    IZO
    PMA / PMN Number
    K950037
    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 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 REPOSITIONED DUE TO INTERMITTENT CAPTURE AT MAXIMUM OUTPUT DUE TO HIGH THRESHOLDS. NO ASYSTOLE WAS OBSERVED. THE INITIAL ISSUE WAS NOTED DURING A ROUTINE FOLLOW-UP IN WHICH THE PATIENT DID NOT FEEL WELL. THE LEAD WAS REPOSITIONED SUCCESSFULLY. THE LEAD REMAINS IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK