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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 01/16/2014
Event Type  Injury  
Event Description

It was reported by the ent physician that the vns patient had laryngeal spasms with stimulation. Additional information was received from the neurologist stating that the patients' vns device settings were decreased to decrease symptoms. The patient did not have a prior history of laryngeal spasms prior to vns. The patient cannot tolerate even low levels of stimulation and his seizure frequency has not changed with vns; however, the patient is experiencing an improved recovery from his seizures with vns therapy.

 
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Brand NamePULSE GEN MODEL 105
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 Key3717906
Report Number1644487-2014-00846
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2015
Device MODEL Number105
Device LOT Number202526
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/06/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/05/2013
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: 04/01/2014 Patient Sequence Number: 1
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