BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1972043 · Received January 27, 2011

    Report

    Report Number
    2649622-2011-00143
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    January 31, 2009
    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
    MN, 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. ANALYSIS SUMMARY - (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS SUMMARY - (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. ANALYSIS SUMMARY - (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED. THE DATE OF DEATH AND CAUSE OF DEATH HAVE BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED. FOLLOW UP WITH CLINIC LATER REPORTED PATIENT HAD CHEST DISCOMFORT THE DAY PRIOR TO DEATH AFTER HAVING RECEIVED ONE APPROPRIATE SHOCK. WENT TO HOSPITAL AND STARTED ON MEDICATIONS WHEN FOUND TO BE IN POLYMORPHIC VENTRICULAR TACHYCARDIA. LATER BECAME DIAPHORETIC AND VERY HYPOTENSIVE. DETERMINED TO BE IN CARDIOGENIC SHOCK, ADMITTED TO ICU AND TREATED MEDICALLY, BUT BY THE NEXT MORNING WAS MADE A DO NOT RESUSCITATE BY THE DAUGHTER, DEVICE WAS TURNED OFF, AND PATIENT DIED WITH CAUSE OF DEATH NOTED TO BE CARDIOGENIC SHOCK DUE TO SEVERE ISCHEMIC CARDIOMYOPATHY. "THE DEVICE WAS FUNCTIONING APPROPRIATELY PRIOR TO HER DEATH." PATIENT WAS NOT PACER DEPENDENT.

    Description of Event or Problem · 1

    ASKU

    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 59 YR Death