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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 02/23/2015
Event Type  Injury  
Event Description

It was reported that a patient experienced ataxia and had visited the er regarding this following a vns generator replacement surgery. The attending neurologist did not believe this incident to be related to vns and further added that the patient had subclinical seizures and not ataxia. Additional information was received stating that the exact time when patient began having the subclinical seizures is unknown and that it was presumed to be sometime after the vns generator replacement surgery. The subclinical seizures were reported to be a new type of seizure for patient. There were no recent medication changes and the only other change was the vns generator replacement. An assessment on the relation of subclinical seizures to vns therapy could not be provided. An eeg was performed and night time aed dosage was increased as interventions. Patient also started physical therapy for gait issues. Patient outcome was reported to be good as far as physician knew.

 
Manufacturer Narrative

(b)(4).

 
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Brand NamePULSE GEN MODEL 104
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 Key4617557
Report Number1644487-2015-04176
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/07/2016
Device MODEL Number104
Device LOT Number205203
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/22/2014
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: 03/19/2015 Patient Sequence Number: 1
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