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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 12/01/2010
Event Type  Injury  
Event Description

It was initially reported by the physician that the pt had an infection and was going to undergo surgery to have her vns generator replaced. Pt was hospitalized due to infection and it was informed that her incision site was opening up and they could see the generator. The surgeon plans to replace the generator and put the new generator in a new pocket. Good faith attempts to obtain additional info has been unsuccessful till date.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1943813
Report Number1644487-2010-02902
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/03/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/03/2010
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

Patient TREATMENT DATA
Date Received: 12/28/2010 Patient Sequence Number: 1
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