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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 12/22/2010
Event Type  Injury  
Event Description

It was initially reported by a nurse that a vns pt had a wound infection and dehiscence with the lead extruding at the superior portion of the chest wall incision. The pt was scheduled to see the neurosurgeon to have his generator and lead removed. Additional info was received from the nurse indicating that at the moment the cause of the reported wound infection and dehiscence with the lead extruding at the superior portion of the chest wall incision was unk. The nurse indicated that the lead and generator were removed on (b)(6) 2011 and cultures were taken, but no growth was seen in 48 hours. Further plans are to have the pt re-implanted in the next month. Good faith attempts to obtain product info have been unsuccessful to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1987529
Report Number1644487-2011-00238
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/11/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/10/2011
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 Received01/11/2011
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

Patient TREATMENT DATA
Date Received: 02/10/2011 Patient Sequence Number: 1
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