BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1923541 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-15313
    Event Type
    Death
    Date Received
    December 14, 2010
    Date of Event
    September 15, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. EVALUATION SUMMARY (B)(4) BATTERY DEPLETION-NORMAL.

    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) BATTERY DEPLETION-NORMAL. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC CUT, BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED 6 DAYS AFTER DEVICE IMPLANT WITH CAUSE OF DEATH PER THE PATHOLOGIST NOTED AS CARDIAC ARRHYTHMIA SECONDARY TO FOCAL MYOCARDIAL HYPOXIA DUE TO HYPOXEMIA INDUCED BY PULMONARY EMBOLISM. FOLLOW UP WITH CORONER REPORTED CAUSE OF THE PULMONARY EMBOLUS HAD NOTHING TO DO WITH THE DEVICE SYSTEM OR DEVICE PROCEDURE. "THE PATIENT WAS INADVERTENTLY GIVEN HIS GASTROSTOMY FEEDING VIA HIS VENOUS SYSTEM. UPON VIEWING THE PATIENT'S BLOOD UNDER A MICROSCOPE, THERE WERE MANY PARTICLES AND FOOD CELLS IN HIS CIRCULATORY SYSTEM WHICH WOUND UP CAUSING THE PE."

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED 6 DAYS AFTER DEVICE IMPLANT WITH CAUSE OF DEATH PER THE PATHOLOGIST NOTED AS CARDIAC ARRHYTHMIA SECONDARY TO FOCAL MYOCARDIAL HYPOXIA DUE TO HYPOXEMIA INDUCED BY PULMONARY EMBOLISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    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 78 YR Death