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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 01/01/2014
Event Type  Injury  
Event Description

Attempts for additional information were unsuccessful.

 
Event Description

It was reported that the patient has been experiencing an increase in seizures. It is unknown if the seizures are above the patient's pre-vns baseline frequency. Attempts to obtain additional information will be made, but no additional information has been received to date.

 
Manufacturer Narrative

 
Event Description

Additional information with device settings were received. The vns duty cycle was adjusted on (b)(6) 2014.

 
Manufacturer Narrative

Adverse event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being corrected to adverse event. Outcomes attributed to adverse event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being updated to show that intervention was taken. Type of reportable event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being corrected to adverse event.

 
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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 Key3657689
Report Number1644487-2014-00580
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2012
Device MODEL Number103
Device LOT Number2877
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/10/2010
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: 03/04/2014 Patient Sequence Number: 1
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