BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 1935171 · Received December 6, 2010

    Report

    Report Number
    1028232-2010-02681
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 26, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    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 IMPLANTABLE RIGHT ATRIAL (RA) LEAD WAS EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THERE WAS ALSO NO CAPTURE AT MAX OUTPUTS. NOISE AND OVERSENSING WERE ALSO REPORTED. THE LEAD WAS PLANNED TO BE REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A LEAD REVISION PROCEDURE WAS SCHEDULED FOR A DATE IN THE NEAR FUTURE. THE RESULTS OF THE CHEST X-RAY DID NOT PROVIDE ANY ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other