BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD-2

    MDR report key: 2811689 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17131
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P890003/S50
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS UNDERSENSING AND NOT PROVIDING ATRIO-VENTRICULAR SYNCHRONY. AS THE INTRODUCER WAS BEING PLACED DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THERE WAS NO PACING THROUGH THE LEAD, AS THE PATIENT WAS NOT DEPENDANT AND THEIR OWN INTRINSIC HEART RATE CAME THROUGH. WHEN THE LEAD WAS TESTED THROUGH THE ANALYZER THERE WERE NO SENSING, IMPEDANCE WAS HIGH, AND THERE WAS NO CAPTURE AT HIGH OUTPUTS. AN X-RAY OF THE LEAD REVEALED A POTENTIAL CRUSH UNDER THE CLAVICLE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE VDD-2 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5038

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR