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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 09/18/2011
Event Type  Death  
Event Description

An obituary search on (b)(6) 2013 showed that this vns patient had passed away on (b)(6) 2011. The patient had been lost to follow-up, and the most recent physician did not know the patient¿s whereabouts. Follow-up with the funeral home showed that the location of the patient¿s device was unknown: it was unknown if the patient was buried with the device. Review of programming history showed that the patient¿s device was still programmed on as of (b)(6) 2011.

 
Manufacturer Narrative

Analysis of programming history.

 
Event Description

It was reported that an autopsy was performed so the vns system was most likely removed during the autopsy. The death certificate indicated that the patient died in the emergency department. The immediate cause of death is listed as chronic seizure disorder complicated by drowning. The manner of death was listed as accident and the injury was described as seizure in bathtub. The coroner indicated that he is certain the device was explanted; however, the facility indicated that they were unable to locate the device. The autopsy report did not list that the vns was explanted. The autopsy reported indicated that there was aspirated foreign material in the patient's airways. The final diagnosis was chronic seizure disorder complicated by drowning, status post implantation of vagal stimulation, cutaneous immersion changes, aspiration of gastric contents, pulmonary edema, and vascular ectasia of left dorsomedial thalamus. There were no significant injuries identified. It was noted that the descendent had an extensive seizure history and was found prone in a bathtub with his face underwater by a staff member of the group care home. Hospitalization records 5-6 months prior to the patient's death showed that the patient was hospitalized from (b)(6) 2011 for physical aggression towards caregivers. The patient was experiencing auditory and visual hallucinations. The patient was discharged in stable condition. The patient was hospitalized again from (b)(6) 2011 due to agitation and abusive behavior toward the care facility staff. The patient was discarded as improved and more stable.

 
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Brand NamePULSE GEN MODEL 104
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3548834
Report Number1644487-2014-00030
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2012
Device MODEL Number104
Device LOT Number2773
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/24/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/02/2014 Patient Sequence Number: 1
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