BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3003363 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00233
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 29, 2013
    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 LEAD WAS UNDERSENSING AND THAT A REVISION PROCEDURE WOULD BE PERFORMED. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION DESCRIBED HOW INTERMITTENT UNDERSENSING OF THE RIGHT ATRIAL LEAD IS LEADING TO DECREASED PACING. IT HAS NOT YET BEEN DECIDED WHETHER A LEAD REVISION WILL OCCUR, OR WHETHER THE DEVICE WILL BE REPLACED WITH A NEWER ONE TO IMPROVE SENSING. 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
    64211 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other