BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1971354 · Received January 27, 2011

    Report

    Report Number
    2649622-2011-00124
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    January 12, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - VENTRICULAR NST<=210 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 07:33:41 AND 07:35:28.

    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 NOTED THE PATIENT DIED WITHIN APPROXIMATELY 6 MONTHS OF DEVICE SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED WITHIN APPROXIMATELY 6 MONTHS OF DEVICE SYSTEM IMPLANT. FOLLOW UP REVEALED THAT PER THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST, DUE TO CONGESTIVE HEART FAILURE DUE TO DILATED CARDIOMYOPATHY. NO AUTOPSY WAS DONE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED WITHIN APPROXIMATELY 6 MONTHS OF DEVICE SYSTEM IMPLANT. FOLLOW UP REVEALED THAT PER THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST, DUE TO CONGESTIVE HEART FAILURE DUE TO DILATED CARDIOMYOPATHY. NO AUTOPSY WAS DONE. FURTHER REPORTED THE MANNER OF DEATH WAS NATURAL.

    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 55 YR Death