BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 4240523 · Received November 10, 2014

    Report

    Report Number
    1028232-2014-004032
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 30, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS PATIENTS DEVICE AND RV LEAD WERE EXHIBITING LOSS OF CAPTURE AND AN INCREASE IN THRESHOLD MEASUREMENTS. THE PATIENT HAD AN UNDERLYING RHYTHM AND NO ASYSTOLE OF GREATER THAN TWO SECONDS WAS NOTED. OVERSENSED NOISE WAS ALSO OBSERVED AND THE FIELD REP. SUSPECTS AN INSULATION ISSUE WITH THE RV LEAD. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME AND THE RV LEAD CONTINUES TO REMAIN IMPLANTED AND IN SERVICE. 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. THE IMPLANT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723012 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 360314

    Patients

    Seq Age Sex Outcome Treatment
    1 Other