BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 4152106 · Received October 8, 2014

    Report

    Report Number
    1028232-2014-003531
    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 PATIENT WITH A RIGHT VENTRICULAR LEAD REPORTED CHEST PAIN. THE LEAD EXHIBITED INCREASED PACING LEAD IMPEDANCE MEASUREMENTS BUT WITHIN NORMAL RANGE. ADDITIONALLY, NO SENSING OR CAPTURE WAS NOTED. A CHEST X-RAY WAS PERFORMED AND SHOWED RV LEAD DISLODGEMENT. THE LEAD TIP APPEARED TO BE BENDING BACK ON ITSELF. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATED THAT THERE WAS NO ASYSTOLE OR LEAD PERFORATION. THIS RV LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630863 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization