BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRODIGY SR

    MDR report key: 1914565 · Received December 3, 2010

    Report

    Report Number
    2647346-2010-00779
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    October 27, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S43
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT RETURNED AND ANALYZED. (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. 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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT 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, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) BATTERY DEPLETION-NORMAL.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED ON THE DEATH CERTIFICATE THAT THE PATIENT DIED ON (B)(6) 2010. THE CAUSE OF DEATH WAS "CARDIAC COLLAPSE" WITH OTHER SIGNIFICANT CONDITIONS BEING CONGESTIVE HEART FAILURE AND PRIOR CLOSED HEAD INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON THE DEATH CERTIFICATE THAT THE PATIENT DIED ON (B)(6) 2010. THE CAUSE OF DEATH WAS "CARDIAC COLLAPSE" WITH OTHER SIGNIFICANT CONDITIONS BEING CONGESTIVE HEART FAILURE AND PRIOR CLOSED HEAD INJURY. FOLLOW UP WITH PHYSICIAN REPORTED CAUSE OF DEATH WAS CARDIO-PULMONARY ARREST, UNRELATED TO PACEMAKER. THE CIRCUMSTANCE OF DEATH WERE END STAGE CARDIOMYOPATHY/CHF, OBSTRUCTIVE SLEEP APNEA WITH CARDIO-PULMONARY CHEYNE-STOKES RESPIRATORY PATTERN. PATIENT WAS LAST SEEN 2 DAYS BEFORE DEATH WITH LAST PACEMAKER CHECK 4 MONTHS BEFORE THAT AT WHICH TIME PACEMAKER WAS PROPERLY FUNCTIONING. FURTHER REPORTED THAT THE DEATH WAS NOT RELATED TO THE DEVICE OR LEAD SYSTEM, PATIENT WAS NOT PACEMAKER DEPENDENT, AND NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODIGY SR ASKU DXY MEDTRONIC MED REL, INC. 8158 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death