BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3043314 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02895
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE EMERGENCY ROOM WITH A HEART RATE OF 30 BPM. DEVICE EVALUATION WAS DONE AND INTERMITTENT LOSS OF CAPTURE WAS NOTED AT OUTPUTS OF 7.5 VOLTS, AND THE PATIENT COULD FEEL THE RV PACING. SURGICAL INTERVENTION WAS PERFORMED, AND THE PHYSICIAN SUSPECTED THE LEAD HAD MICRODISLODGED BECAUSE ON FLUOROSCOPY THE LEAD LOOKED TO BE IN THE SAME POSITION. THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147367 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R