Description of Event or Problem · 1
MFR PERIODICALLY COMPARES DEVICE TRACKING INFO TO THE SOCIAL SECURITY DEATH INDEX FOR THE PURPOSE OF UPDATING DEVICE TRACKING DATA. MFR BECAME AWARE OF PATIENT DEATH DURING THIS PROCESS AND EVALUATED AVAILABLE INFO AGAINST CURRENT PROCEDURES. THE EVENT DID NOT MEET MDR REPORTING CRITERIA PER MFR'S CURRENT PROCEDURES. IN AN EFFORT TO OBTAIN ADDITIONAL INFO REGARDING PATIENT DEATHS FOR SUMMARY REPORTING REQUEST, CERTIFICATE OF DEATH WAS REQUESTED, RECEIVED AND REVIEWED BY MFR. DEATH CERTIFICATE INDICATES THAT PATIENT DIED WHILE HOSPITALIZED. IMMEDIATE CAUSE OF DEATH IS LISTED AS ACUTE RENAL FAILURE (FOR 3 DAYS DURATION), DUE TO OR AS A CONSEQUENCE OF ACUTE ANASARCA (FOR 7 DAYS DURATION), DUE TO OR AS A CONSEQUENCE OF ACUTE PULMONARY FAILURE (FOR 7 DAYS DURATION), DUE TO OR AS A CONSEQUENCE OF SEPSIS (FOR 7 DAYS DURATION). NO AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL 7 DAYS PRIOR TO DEATH IN HYPOVOLEMIC SHOCK AND NEVER RECOVERED. IT WAS REPORTED THAT THE PATIENT WAS SEIZURE-FREE WITH THERAPY AS OF LAST VISIT WITH NEUROLOGIST. THE PATIENT WAS RECEIVING THERAPY AT THE TIME OF DEATH AND WAS LAST SEEN BY TREATING NEUROLOGIST APPROX 10 MONTHS PRIOR TO DEATH. NEUROLOGIST INDICATED THAT PATIENT'S DEATH WAS NOT RELATED TO THE NCP SYSTEM. THERE IS NO EVIDENCE THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, BASED ON THE REPORTED CAUSE OF DEATH, ALTHOUGH IT IS NOT BELIEVED THAT IT IS LIKELY THAT THE VNS THERAPY CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, IT CANNOT BE DEFINITIVELY RULED OUT AS A FACTOR.