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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 04/01/2006
Event Type  Injury  
Event Description

Reporter indicated that they were experiencing numbness and pain in the neck. Later information was received that the pt underwent surgery to have the device removed, but the surgeon's office is unsure of why the device was to be removed. All attempts for more information have been unsuccessful, and thus the relationship between events and vns therapy cannot be determined. Attempts to have the products returned to the manufacturer for analysis 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 Key1368996
Report Number1644487-2009-00812
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Type of Report Initial
Report Date 03/24/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2007
Device MODEL Number102
Was Device Available For Evaluation? No
Date Manufacturer Received03/24/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2006
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: 04/22/2009 Patient Sequence Number: 1
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