BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1935593 · Received December 22, 2010

    Report

    Report Number
    2649622-2010-15365
    Event Type
    Death
    Date Received
    December 22, 2010
    Date of Event
    November 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    FOLLOW UP INFORMATION RECEIVED FROM THE FUNERAL HOME INDICATED THE CAUSE OF DEATH WAS DILATED CARDIOMYOPATHY. NO AUTOPSY WAS COMPLETED. CIRCUMSTANCES SURROUNDING PATIENT DEATH AS REPORTED ON AMBULANCE RECORD AND HOSPITAL RECORDS INDICATE THE PATIENT YELLED OUT TO SPOUSE FOR HELP, WAS FOUND SLIDING DOWN THE WALL ONTO THE FLOOR AND SPOUSE ATTEMPTED RESUSCITATION. EMERGENCY SERVICES ARRIVED, RESUSCITATION EFFORTS WERE CONTINUED INCLUDING INTUBATION, THERAPY FOR VENTRICULAR FIBRILLATION, PULSELESS ELECTRICAL ACTIVITY, THERAPY RECEIVED FOR VENTRICULAR TACHYCARDIA BUT PATIENT WAS DECLARED DEAD AT THE EMERGENCY ROOM. LAST DEVICE REPORT APPROXIMATELY SIX WEEKS PRIOR TO THE PATIENT'S DEATH INDICATED ATRIAL PACING OF 50.15%, VENTRICULAR PACING OF 98.41%, NORMAL DEVICE FUNCTION. THE LAST VISIT WITH THE PRIMARY CARDIOLOGIST FOUR WEEKS BEFORE DEATH INDICATED AN ABNORMAL OPTIVOL READING AND FLUID LEVELS HAD BEEN INCREASING SINCE (B)(4) OF 2010. A VISIT TO THE CONGESTIVE HEART FAILURE CLINIC THREE WEEKS BEFORE DEATH INDICATED THE PATIENT RECEIVED A DOBUTAMINE INFUSION AND LABS SHOWED AN ELEVATED CREATININE. 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 THAT THE PATIENT DIED JUST OVER TWO MONTHS POST IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

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