BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1810593 · Received August 23, 2010

    Report

    Report Number
    2649622-2010-08866
    Event Type
    Death
    Date Received
    August 23, 2010
    Date of Event
    August 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FOLLOW UP WITH PHYSICIAN REPORTED PATIENT WENT INTO VT/VF ARREST DURING OR AFTER ENDOSCOPY PROCEDURE. THE STAFF IN THE PROCEDURE ROOM DID NOT KNOW HOW TO DEAL WITH THE MAGNET SO THEY EXTERNALLY DEFIBRILLATED THE PATIENT SUCCESSFULLY, BUT WERE NEVER ABLE TO REALLY STABILIZE THE PATIENT. PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT ON A VENTILATOR. PHYSICIAN FELT THE DRUGS GIVEN FOR THE PROCEDURE PROBABLY CAUSED HER TO DECOMPENSATE AS HER EJECTION FRACTION WAS ONLY 10%. THE PATIENT WAS IN END STAGE HEART FAILURE AND IT WAS A FAMILY DECISION TO TAKE HER OFF THE VENTILATOR AND NOT PROLONG HER LIFE. CAUSE OF DEATH IS END STAGE HEART FAILURE. PHYSICIAN STATED AT FIRST HE THOUGHT THERE MAY HAVE BEEN A LEAD MALFUNCTION, BUT REALIZED WHAT HE SAW WAS DUE TO EXTERNAL DEFIBRILLATION, OTHERWISE NO PERFORMANCE CONCERNS.

    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 WENT INTO VENTRICULAR FIBRILLATION DURING AN ENDOSCOPY PROCEDURE. A MAGNET WAS IN PLACE DURING THE PROCEDURE "POTENTIALLY DELAYING DETECTION." THE LEAD INTEGRITY ALERT HAD BEEN TRIGGERED DUE TO SHORT INTERVAL COUNT OF 120 AND NONSUSTAINED TACHYCARDIAS WITH FAST CYCLE LENGTHS. THE ALERT EVENTS DO NOT HAVE THE LIA ALERT LISTED, BUT RATHER STATES "??? INVALID DATA RECEIVED FOR EVENT." THE PATIENT IS REPORTED TO HAVE 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 THE PATIENT WENT INTO VENTRICULAR FIBRILLATION DURING AN ENDOSCOPY PROCEDURE. A MAGNET WAS IN PLACE DURING THE PROCEDURE "POTENTIALLY DELAYING DETECTION." THE LEAD INTEGRITY ALERT HAD BEEN TRIGGERED DUE TO SHORT INTERVAL COUNT OF 120 AND NONSUSTAINED TACHYCARDIAS WITH FAST CYCLE LENGTHS. THE ALERT EVENTS DO NOT HAVE THE LIA ALERT LISTED, BUT RATHER STATES " INVALID DATA RECEIVED FOR EVENT." PATIENT IS REPORTED TO HAVE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW ASKU DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| L| R