BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 4152112 · Received October 8, 2014

    Report

    Report Number
    1028232-2014-003538
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    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 WAS POSSIBLY DISLODGED. SUBSEQUENTLY, IT WAS REPORTED THAT THE LEAD WOULD CAPTURE ONLY AT HIGHER VOLTAGES AND THAT THE PATIENT COULD FEEL PACING AT HIGHER OUTPUT. THERE WAS NO ASYSTOLE DETECTED. THE DEVICE WAS PROGRAMMED TO AAI. FURTHERMORE, AN X-RAY WAS DONE AND CONFIRMED THE LEAD HAD DISLODGED. THE LEAD WAS THEN SUCCESSFULLY REPOSITIONED. 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
    630865 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization