BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 1971355 · Received January 27, 2011

    Report

    Report Number
    2647346-2011-00048
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    January 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    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. 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.

    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

    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

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death