BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1902633 · Received November 18, 2010

    Report

    Report Number
    2649622-2010-12094
    Event Type
    Death
    Date Received
    November 18, 2010
    Date of Event
    July 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 BY EMERGENCY MEDICAL SERVICE RECORDS THAT THE PATIENT WAS FOUND DOWN AT HOME. FAMILY MEMBER ATTEMPTED CPR, BUT THE PATIENT WAS UNRESPONSIVE, PULSELESS AND IN PULSELESS ELECTRICAL ACTIVITY. EMS ATTEMPTED RESUSCITATION AT THE PATIENT'S HOME AND DURING TRANSPORTATION TO THE HOSPITAL EMERGENCY ROOM. DURING TRANSPORTATION THE RHYTHM CHANGED TO ASYSTOLE AND REMAINED IN ASYSTOLE AT THE EMERGENCY ROOM. THE PATIENT DIED ON (B)(6) 2010. NO AUTOPSY WAS PERFORMED AND THE CLINICAL IMPRESSION/DIAGNOSIS WAS CARDIAC ARREST. PATIENT LAST SEEN IN CLINIC APPROXIMATELY ONE MONTH PRIOR TO DEATH AND WAS NOT PACEMAKER DEPENDENT. THERE WERE "NO DEVICE ISSUES THEY ARE AWARE OF" AND "NO EPISODES, NO ABNORMAL FINDINGS, DEVICE CHECK WAS GOOD". THE DEVICE WAS NOT EXPLANTED. "THEY DO NOT KNOW WHAT THE OFFICIAL CAUSE OF DEATH WAS".

    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 53 YR Death