BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2082826 · Received April 29, 2011

    Report

    Report Number
    1028232-2011-00970
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    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 TWO DAYS POST IMPLANT THE THRESHOLD MEASUREMENT HAD INCREASED FROM 0.6 VOLTS TO 1.3 VOLTS AT 0.5 MS. ALL OTHER LEAD DIAGNOSTICS WERE WITHIN NORMAL LIMITS. AUTO CAPTURE WAS PROGRAMMED ON IN THE DEVICE AND UPON INTERROGATION THE DEVICE WAS IN RETRY AND THERE WAS INTERMITTENT LOSS OF CAPTURE. THE PT'S RATE DROPPED BETWEEN 30 TO 40 BPM, HOWEVER THE DEVICE WAS PROGRAMMED WITH A LOWER RATE LIMIT OF 60 PPM. THE PT DID HAVE AN INTRINSIC RHYTHM AT 40 BPM, BUT WAS SYMPTOMATIC WHEN PACING AT THIS RATE. BOSTON SCIENTIFIC TECHNICAL SERVICES ADVISED THE SALES REPRESENTATIVE (SR) TO HAVE A CHEST X-RAY PERFORMED ON THE PT TO DETERMINE IF THERE WAS A LEAD DISLODGEMENT. AN EMAIL WAS SENT TO SR IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT 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