BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1891696 · Received November 5, 2010

    Report

    Report Number
    2649622-2010-12042
    Event Type
    Death
    Date Received
    November 5, 2010
    Date of Event
    August 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.

    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. (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED EIGHTEEN DAYS AFTER DEVICE EXPLANT. FOLLOW UP LATER REVEALED PATIENT ADMITTED TO HOSPITAL SIX DAYS PRIOR TO DEATH WITH ELEVATED TEMPERATURE, CHILLS, SHORTNESS OF BREATH. DIAGNOSED WITH PNEUMONIA AND PROBABLE LEFT LEG CELLULITIS. TRANSFERRED TO INTENSIVE CARE UNIT AFTER BECOMING UNRESPONSIVE, FAMILY OPTED TO MAKE THE PATIENT A DO NOT RESUSCITATE, AND THE PATIENT DIED. FINAL DIAGNOSIS WAS SEPTICEMIA, PNEUMONIA, ACUTE KIDNEY FAILURE, ACUTE RESPIRATORY FAILURE, DIABETES (TYPE 2), SYSTOLIC HEART FAILURE, CHRONIC KIDNEY DISEASE, PAROXYSMAL VENTRICULAR TACHYCARDIA, ATRIAL FIBRILLATION, PRIMARY CARDIOMYOPATHY, LOWER LIMB ULCER, SEPSIS. THERE WAS NO ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED EIGHTEEN DAYS AFTER DEVICE EXPLANT. 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 ASKU LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| L| R