BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN COMMAND

    MDR report key: 1739264 · Received June 29, 2010

    Report

    Report Number
    2649622-2010-06854
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    June 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DQY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. SN UPDATED TO CORRECTED NUMBER - (B)(4).

    Additional Manufacturer Narrative · 1

    (B) (4)

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THERE IS NO MANUFACTURING DATE AVAILABLE FOR (B) (4) AT THE TIME OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE MANUFACTURING DATE IS DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A NORMAL IMPLANT OF THE DEVICE AND THE RV AND RA LEADS. THE CS WAS ENTERED WITH THE (B) (4) AND THE VENOGRAM SHOWED SEVERAL OPPORTUNITIES FOR PLACING THE LV LEAD. WITH THE INNER CATHETER (B) (4), A SUBSELECTIVE VENA WAS FOUND. HOWEVER, THE LEAD WAS NOT ABLE TO PASS AFTER APPROXIMATELY 5CM "IN VENA" AND AFTER SEVERAL ATTEMPTS TO GUIDE THE LEAD INTO THE VENA, "GUIDING CATHETER WAS POUCHED OUT OF THE SUB SELECTED VENA." DURING THE NEXT ATTEMPT TO ENTER POSTERIOR/LATERAL VENA HIGH IN CS, SUDDENLY THE PATIENT LOST CONSCIOUSNESS. RESUSITATION ATTEMPTS WERE UNSUCCESSFUL AND THE PATIENT DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A NORMAL IMPLANT OF THE DEVICE AND THE RV AND RA LEADS. THE CS WAS ENTERED WITH THE 6250MP AND THE VENOGRAM SHOWED SEVERAL OPPORTUNITIES FOR PLACING THE LV LEAD. WITH THE INNER CATHETER 6248DEL, A SUBSELECTIVE VENA WAS FOUND. HOWEVER,THE LEAD WAS NOT ABLE TO PASS AFTER APPROXIMATELY 5CM "IN VENA" AND AFTER SEVERAL ATTEMPTS TO GUIDE THE LEAD INTO THE VENA, "GUIDING CATHETER WAS POUCHED OUT OF THE SUB SELECTED VENA." DURING THE NEXT ATTEMPT TO ENTER POSTERIOR/LATERAL VENA HIGH IN CS, SUDDENLY THE PATIENT LOST CONSCIOUSNESS. RESUSITATION ATTEMPTS WERE UNSUCCESSFUL AND THE PATIENT DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. ADDITIONAL INFORMATION REPORTED NO AUTOPSY WAS DONE. CAUSE OF DEATH REPORTED TO BE COMPLICATIONS DURING IMPLANT, PROBABLY A PEA (PULSELESS ELECTRICAL ACTIVITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN COMMAND LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC PUERTO RICO, INC. 6250MPX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death