BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3051535 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04885
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. CONCOMITANT PRODUCTS: D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  IMPLANTED: (B)(6) 2011, 694865 IMPLANTABLE TACHY LEAD IMPLANTED: (B)(6) 2006, 419488 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO RECEIVING MULTIPLE SHOCKS FOR LEAD NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ELEVATED SHORT V-V INTERVAL COUNT AND HIGH IMPEDANCE. THE LEAD WAS NOTED TO BE FRACTURED. IT WAS ALSO NOTED THERE WAS BLOOD INGRESS WHICH AFFECTED THE LEAD IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. DURING THE RV LEAD EXTRACTION PROCEDURE, THE ATRIAL LEAD WAS AFFECTED. THE LEADS WERE EXPLANTED AND REPLACED. IT ALSO REPORTED THAT THE PROGRAMMER CRASHED IN THE MIDDLE OF A WIRELESS SESSION. IT OCCURRED AFTER INSERTION OF THUMB DRIVE. THE GREEN USB ICON DID NOT SHOW UP AS GREEN. ANOTHER PROGRAMMERWAS USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149771 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R