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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
Event Date 01/12/2011
Event Type  Injury  
Event Description

It was reported through clinic notes dated (b)(6) 2009 that a vns pt was having more frequent seizures and went to the hospital. The patient's keppra was lowered as an intervention and as a result of the hospital visit a bladder infection was diagnosed. Further review of the notes indicated the pt had blackouts and were considered to be related to the patient's seizure nature. At the moment, the relationship of the frequent seizures to the infection is unk as good faith attempts to obtain additional info have been unsuccessful to date.

 
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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 Key1993868
Report Number1644487-2011-00242
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2005
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/12/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2003
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: 02/11/2011 Patient Sequence Number: 1
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