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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC. PULSE GEN MODEL 102

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CYBERONICS INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Device Problem Insufficient Information
Event Date 06/05/2009
Event Type  Malfunction  
Event Description

It was reported that a vns patient experienced an increase in seizures along with ear, neck, and jaw pain that were related to stimulation. Information from the treating neurologist indicated the increase in seizures was approximately pre-vns baseline or more and the seizure amount would vary. Diagnostics performed on the patient indicated the device to be working within normal limits. The neurologist decreased the output current which resolved the pain events, but started the seizures after decreasing the parameters. Further interventions are to monitor the patient and check the diagnostics.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1486451
Report Number1644487-2009-01688
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 07/16/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2005
Device MODEL Number102
Device LOT Number009273
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/16/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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