BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1675555 · Received May 6, 2010

    Report

    Report Number
    2649622-2010-01917
    Event Type
    Death
    Date Received
    May 6, 2010
    Date of Event
    November 7, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. EVALUATION SUMMARY: (B) (4) ANALYSIS OF THE RETURNED LEAD FOUND NO ANOMALIES; THE FULL LEAD WAS RETURNED. VISUAL ANALYSIS NOTED THE PROXIMAL CONDUCTOR IS DISTORTED, THERE IS BLOOD/BODY FLUID IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE BLOOD IN THE DISTAL CONDUCTOR MOST LIKELY ENTERED THROUGH THE IS-1 PIN AS NO INNER INSULATION BREACH WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM. A TEMPORARY PACEMAKER WAS PLACED, AND THE PATIENT WAS UNRESPONSIVE WHEN TRANSFERRED TO THE CVC. THE PHYSICIAN ATTEMPTED TO IMPLANT A DUAL CHAMBER DEVICE, AND HAD PLACED BOTH THE ATRIAL AND VENTRICULAR LEAD. WHILE PREPARING TO PLACE THE DEVICE, THE ATRIAL LEAD DISLODGED. THE PATIENT WAS IN PULSELESS ELECTRICAL ACTIVITY (PEA) AT THIS TIME. THE ATRIAL LEAD WAS REMOVED, AND THE PHYSICIAN REQUESTED A SINGLE CHAMBER DEVICE. THE PATIENT REMAINED IN PEA. A CODE WAS CALLED AND RESUSITATION WAS ATTEMPTED; HOWEVER, THE PATIENT DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death| L| R