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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. DEMIPULSE GEN MODEL UNK GENERATOR

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CYBERONICS, INC. DEMIPULSE GEN MODEL UNK GENERATOR Back to Search Results
Model Number 103
Event Date 07/23/2013
Event Type  Death  
Event Description

It was reported that the vns patient died the month prior. No other information was provided. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

Additional information was received stating that the patient¿s immediate cause of death was ventricular fibrillation arrest and aspiration pneumonia with a contributory condition of dvt¿s (deep venous thrombi). No autopsy was performed. The patient¿s body was cremated and the device was not explanted prior to cremation. Approximately one month prior to the patient¿s death, the patient went to the er on (b)(6) 2013 due to increased lethargy and being unaroused. The patient improved during his work-up at the er, and it was the medical opinion that he was ¿most likely suffering from a postictal state that is recovering slowly. ¿ he was not admitted to the hospital and was released to return to his home with continuation of his baseline medications. The clinical impression was ¿altered mental status ¿ resolved¿. On (b)(6) 2013, the patient developed a high fever at the group home facility, seemed lethargic to caregivers, and was having a lot of coughing. The patient was experiencing respiratory failure with low oxygen saturation, a urinary tract infection, and evidence of pneumonia on a ct scan. He was given antibiotics based on his high risk for aspiration due to swallowing difficulty. An endotracheal tube was placed to facilitate oxygenation that markedly improved. The patient was admitted to the icu on mechanical ventilation and was in critical condition at the time of admission. Medical records of the hospitalization indicate that the patient was admitted with fever and subsequently diagnosed with pneumonia (aspiration related). The patient required intubation, he self-extubated , and was then re-intubated. It was decided by a caregiver to avoid extraordinary procedures and to offer comfort only support and he died a few days later due to sudden ventricular fibrillation and cardiac arrest.

 
Manufacturer Narrative

Date received by manufacturer; corrected data: this date on follow-up mfr. Report #01 was inadvertently reported incorrectly. The date should have been 09/15/2014 rather than 09/16/2014. The report was submitted within the 30 day deadline with the date change.

 
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Brand NameDEMIPULSE GEN MODEL UNK
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 Key3342878
Report Number1644487-2013-02662
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/14/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number103
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/31/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/11/2013 Patient Sequence Number: 1
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