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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 12/28/2010
Event Type  Injury  
Event Description

It was reported that the vns patient was diagnosed with laryngomalacia and had severe obstructive sleep apnea (osa). The neurologist did not comment on the patient¿s laryngomalacia diagnosis as it was made by another physician. The neurologist stated that the patient¿s osa got worse with vns and that it was occurring with stimulation. The neurologist is planning to change the device¿s programmed settings but has not occurred to date. No causal or contributory programming or medication changes preceded the onset of the osa. The patient has a medical history of osa. The patient¿s osa and laryngomalacia were followed for many years. Clinic notes were received for the patient¿s office visit with his neurologist on (b)(6) 2014. The notes indicate that the patient¿s parent was considering having the patient¿s device programmed off to alleviate his osa symptoms. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.

 
Event Description

Additional information was received stating that the vns is not believed to have caused the onset of laryngomalacia as it is usually a condition that one is born with. The patient was diagnosed with laryngomalacia in 2013 when attending a sleep apnea evaluation. The patient had a diagnostic bronchoscopy exam and was prescribed with reflux medications for laryngomalacia in addition to the medications for sleep apnea.

 
Manufacturer Narrative

Describe event or problem; corrected data: additional information indicates that the patient was diagnosed with laryngomalacia in 2013. The initial manufacturer report stated that this issue was followed for many years.

 
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Brand NamePULSE GEN MODEL 103
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 Key3725306
Report Number1644487-2014-00852
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2012
Device MODEL Number103
Device LOT Number2834
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/08/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/08/2010
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: 04/03/2014 Patient Sequence Number: 1
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