BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASKU

    MDR report key: 1895232 · Received November 10, 2010

    Report

    Report Number
    2183613-2010-00292
    Event Type
    Death
    Date Received
    November 10, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 29, 2010
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. THIS SUPPLEMENTAL IS BASED SOLELY ON THE RECEIPT OF A 3500A REPORT. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PACEMAKER WAS CONNECTED TO A PATIENT WHO WAS AMBULATORY. THE PATIENT WAS FOUND DEAD ON THE BATHROOM FLOOR WITH A MASSIVE HEAD INJURY AND THE VENTRICULAR LEAD FROM THE DEVICE WAS UNATTACHED. FOLLOW UP REVEALED THAT PER THE CORONER, "PATIENT'S DEATH WAS NOT RELATED TO THE 5388 EPG, BUT FROM A MASSIVE HEAD INJURY." FURTHER REPORTED THE 5388 WAS REATTACHED TO THE PATIENT AFTER PATIENT FOUND DOWN AND THE 5388 WAS WORKING CORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED EXTERNAL PACEMAKER WAS CONNECTED TO PATIENT WHO WAS AMBULATORY. PATIENT FOUND DEAD ON BATHROOM FLOOR WITH MASSIVE HEAD INJURY AND VENTRICULAR LEAD FROM DEVICE WAS UNATTACHED. CORONER REPORTED "PATIENT'S DEATH WAS NOT RELATED TO THE (B)(4) EPG, BUT FROM A MASSIVE HEAD INJURY." (B)(4) WAS REATTACHED TO PATIENT AFTER PATIENT FOUND DOWN AND THE (B)(4) WAS WORKING CORRECTLY. NO INFORMATION PROVIDED ON MODEL AND MANUFACTURER OF TEMPORARY LEADS. LATER FOLLOW UP REVEALED TEMPORARY WIRES WERE PLACED IN RV AND RA AND PATIENT WAS A-V SEQUENTIALLY PACED DUE TO NO UNDERLYING PERFUSING RHYTHM AFTER AORTIC VALVE REPLACEMENT SURGERY. WAS BELIEVED PATIENT GETTING UP TO USE RESTROOM WHEN RV WIRE BECAME DETACHED FROM (B)(4). PATIENT FELL AND PER TELEMETRY STRIP, APPROXIMATELY 32 SECONDS OF NO VENTRICULAR CAPTURE, HOWEVER, UPON RE-ATTACHING THE RV WIRE TO (B)(4), CAPTURE RE-ESTABLISHED. NO AUTOPSY WAS DONE AND TEMPORARY WIRES DISPOSED OF.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PACEMAKER WAS CONNECTED TO A PATIENT WHO WAS AMBULATORY. THE PATIENT WAS FOUND DEAD ON THE BATHROOM FLOOR WITH A MASSIVE HEAD INJURY AND THE VENTRICULAR LEAD FROM THE DEVICE WAS UNATTACHED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU ASKU DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death