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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 10/28/2016
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient was hospitalized due to feeling sick and having a few seizures, which were not alleged to be related to the patient's vns. The patient was intubated and experienced cardiac arrest while in the emergency department. The patient was then transferred to the icu, and a brain mri was scheduled. It was later reported that the patient was placed on life support on (b)(6) 2016 and was deemed brain dead. The patient passed away on (b)(6) 2016, and the device was not explanted. Attempts for further information were unsuccessful to date.

 
Event Description

The physician provided the patient's device settings, but diagnostic results were not provided. No further relevant information has been received to date.

 
Event Description

The death summary from the patient's hospitalization was provided. The patient presented at the emergency room after he had a seizure, administered ativan, and was taken to the hospital by emergency medical services. The patient had a history of seizure disorders and developmental delay. The patient also had a urinary tract infection. The initial assessment upon the patient's arrival was encephalopathy postanoxic, postictal cardiac arrest, pulseless electrical activity (pea), postanoxic myoclonus, status epilepticus, acute respiratory failure, and elevated hepatic enzymes. The patient was given antiepileptic medications while in the hospital. The patient also had evidence of kidney injury, and the assessment was acute kidney injury, metabolic acidosis, and anemia. The patient was in the icu, and the assessment was that the patient had respiratory to cardiac arrest, secondary to seizure and ativan administration. A chest x-ray revealed a left lower lobe infiltrate and presumptive pneumonia. Subsequent to this, the patient remained in an anoxic state and ventilator dependent. An mri was performed, which was consistent with anoxic brain injury. The patient's family and physicians decided to remove the patient from life support, and the patient passed away due to respiratory failure secondary to anoxic encephalopathy.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key6122170
Report Number1644487-2016-02715
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/22/2016
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/27/2018
Device MODEL Number106
Device LOT Number203712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/29/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2016
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: 11/22/2016 Patient Sequence Number: 1
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