BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1905447 · Received November 23, 2010

    Report

    Report Number
    2649622-2010-12125
    Event Type
    Death
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ASKU

    Additional Manufacturer Narrative · 1

    ASKU

    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 PATIENT HAD AN "EPISODE" ON THE DAY OF DEATH (B)(6) 2010 - ONE SHOCK OF 20 JOULES THAT WAS SUCCESSFUL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND DIED LATER THAT DAY. FURTHER REPORTED "DID NOT APPEAR TO BE ANY MALFUNCTION OF DEVICE/LEADS." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN EPISODE ON THE DAY OF DEATH (B)(6) 2010 - ONE SHOCK OF 20 JOULES THAT WAS SUCCESSFUL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND DIED LATER THAT DAY. FURTHER REPORTED "DID NOT APPEAR TO BE ANY MALFUNCTION OF DEVICE/LEADS." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP LATER REVEALED THE PATIENT'S DEVICE HAD BEEN "WORKING WITHIN NORMAL PARAMETERS." THE CLINIC NURSE REPORTED THE PATIENT HAD MANY COMORBIDITIES AND HER DEATH WAS NOT DEVICE RELATED. LATER REPORTED THAT ACCORDING TO PARAMEDICS, PATIENT WAS IN PACED RHYTHM, BUT WAS IN A SINUS RHYTHM WHILE HOSPITALIZED. THE PATIENT ARRESTED, THE FAMILY OPTED TO WITHHOLD FURTHER RESUSITATION, AND THE PATIENT DIED. THE FINAL DIAGNOSIS WAS REPORTED TO BE CARDIAC ARREST, "UNCLEAR EXACTLY WHAT CAUSED THIS ARREST."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN EPISODE ON THE DAY OF DEATH (B)(6) 2010 - ONE SHOCK OF 20 JOULES THAT WAS SUCCESSFUL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND DIED LATER THAT DAY. FURTHER REPORTED "DID NOT APPEAR TO BE ANY MALFUNCTION OF DEVICE/LEADS." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP LATER REVEALED THE PATIENT'S DEVICE HAD BEEN "WORKING WITHIN NORMAL PARAMETERS." THE CLINIC NURSE REPORTED THE PATIENT HAD MANY COMORBIDITIES AND PATIENT'S DEATH WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 4592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| L| R