BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2003333 · Received March 1, 2011

    Report

    Report Number
    2649622-2011-03118
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    February 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 THE RIGHT VENTRICULAR LEAD WAS IMPLANTED AND TESTED WITH GOOD NUMBERS - THRESHOLD OF 1V AT 0.5 MILLISECONDS. WITHIN ABOUT TWO MINUTES, THE PATIENT DROPPED HIS BLOOD PRESSURE AND WAS IN PULSELESS ELECTRICAL ACTIVITY. EXTERNAL PACING WAS ATTEMPTED AND HIGH OUTPUT PACING WITH THE LEAD, BUT THERE WAS NO CAPTURE. RESUSITATION EFFORTS CONTINUED FOR APPROXIMATELY 20 MINUTES, BUT THE PATIENT DIED. AN ECHOCARDIGRAM WAS DONE AND DEMONSTRATED THERE HAD BEEN NO PERFORATION OR PNUEMOTHORAX. FURTHER REPORTED THE CAUSE OF DEATH IS UNKNOWN AT PRESENT. THE PHYSICIAN DOES NOT HAVE ANY ALLEGATION AGAINST THE LEAD AS RELATES TO THE PATIENT DEATH. PATIENT WAS NOT PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R