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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNKNOWN

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CYBERONICS, INC. PULSE GEN MODEL UNKNOWN Back to Search Results
Event Date 04/21/2011
Event Type  Malfunction  
Event Description

It was reported via poster presentation entitled "vagus nerve stimulator in a pediatric population-surgical technique considerations in young children" that one pt underwent revision surgery due to dehiscence wound and possible mechanical problems. No further details given and attempts for further info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNKNOWN
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key2102364
Report Number1644487-2011-01154
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/20/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/20/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/20/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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