BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 3984405 · Received August 6, 2014

    Report

    Report Number
    1028232-2014-002733
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 23, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE WITH LESS THAN 2 SECONDS OF ASYSTOLE ALONG WITH HIGH PACING THRESHOLD MEASUREMENTS. LEAD DISLODGEMENT WAS PRESUMED, HOWEVER, NOT CONFIRMED. THE RV LEAD WAS EXPLANTED AND REPLACED. THE LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED BY THE HOSPITAL STAFF. 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
    461944 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization