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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 01/27/2012
Event Type  Injury  
Event Description

It was reported by a physician that a vns patient experienced an increase in seizures due to unknown reason 40 days after a change in settings. Interventions take by the physician were to adjust the parameters on the patient due to the increase in seizures. At the moment it is unknown if the change in settings is correlated to the increase in seizures as good faith attempts to obtain further information have been unsuccessful to date.

 
Event Description

Additional information was received from the treating physician indicating the unpleasant stimulation was solved by lowering the settings. The worsening in focal seizures was likely attributed to the lowering of settings.

 
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Brand NamePULSE GEN MODEL 104
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2495757
Report Number1644487-2012-00753
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number104
Device LOT Number2309
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/29/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2009
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: 03/19/2012 Patient Sequence Number: 1
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