Description of Event or Problem · 1
REPORTER INDICATED THAT VNS PATIENT HAD PASSED AWAY OF APPARENT SUICIDE. REPORT IS INCOMPLETE BECAUSE NO REPONSE HAS BEEN RECEIVED TO MANUFACTURER'S REQUESTS FOR ADDITIONAL INFORMATION (VIA TELEPHONE X2, FAX X2. THERE IS NO EVIDENCE AT THIS TIME THAT THE VNS THERAPY SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS SPECIFIC PATIENT HAD A KNOWN HISTORY OF SUICIDAL IDEATION WHICH IS LIKELY THE PREDOMINANT FACTOR LEADING TO THE PATIENT'S DEATH. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION BY ANY MEDICAL PROFESSIONAL AND CYBERONICS, INC., IS NOT AWARE OF ANY MALFUNCTION THAT HAS LEAD TO INCREASED SUICIDAL TENDENCIES. VNS THERAPY IS AN ADJUNCTIVE THERAPY FOR THE TREATMENT OF PATIENTS WITH TREATMENT RESISTANT DEPRESSION. GENERALLY SPEAKING, THESE PATIENTS ARE BY DEFINITION THE MOST SEVERELY DEPRESSED AND HAVE NOT HAD SUCCESSSFUL TREATMENTS PRIOR TO VNS THERAPY IMPLANTATION. THE BENEFIT OF VNS THERAPY TREATMENT FOR DEPRESSION IS NOT INMEDIATE, IN FACT, THE FDA APPROVED LABELING STATES THAT IMPROVEMENT MAY TAKE MONTHS AND PATIENTS SHOULD CONTINUE TREATMENT AS USUAL. THIS PATIENT WAS IMPLANTED LESS THAN ONE MONTH. ADDITIONALLY, DEVICE LABELING CAUTIONS THAT THE SAFETY AND EFFICACY OF THE VNS THERAPY SYSTEM HAVE NOT BEEN ESTABLISHED FOR USES OUTSIDE THE "INTENDED USE/INDICATIONS" SECTION OF THE PHYSICIAN'S MANUAL, INCLUDING (BUT NOT LIMITED TO) PATIENTS WITH ACUTE SUICIDAL THINKING OR BEHAVIOR.