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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
Device Problem Device Operates Differently Than Expected
Event Date 06/01/2012
Event Type  Injury  
Event Description

It was reported that the vns patient began experiencing grand mal seizures approximately three years ago following initial vns implant. The patient had not experienced these types of seizures in the past. The patient¿s parent indicated that vns was effective in controlling her other types of seizures but not effective in controlling grand mal seizures. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Additional information received indicates that the provider is aware that the patient has grand mal seizures but does not believe the emergence of this seizure type to be related to the patient's vns device. The provider states that in addition to vns therapy the patient is being treated medically for all of her seizures types.

 
Event Description

The provider reported that the parent's reports of patient movements were considered psychogenic by another provider. Clinic notes were provided indicating that the events reported by the parents were ultimately determined to be abnormal behavioral movements and likely not seizures. Any actual seizures the patient was experiencing were attributed to the patient starting oral contraceptives.

 
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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 Key4874395
Report Number1644487-2015-05041
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup
Report Date 06/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2012
Device MODEL Number104
Device LOT Number2656
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/11/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/04/2010
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: 06/29/2015 Patient Sequence Number: 1
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