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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102 NONE

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CYBERONICS INC PULSE GEN MODEL 102 NONE Back to Search Results
Model Number 102
Event Date 12/02/2008
Event Type  Injury  
Event Description

Reporter indicated a vns patient had poor wound healing and developed an infection and wound dehiscence at the vns generator and electrode incision sites. The patient's poor wound healing and wound dehiscence are attributed to patient trauma of picking at the incisions, poor hygiene, and possibly coumadin medication. The patient later underwent explant of the vns generator only. The explanted generator has been returned and is currently in product analysis.

 
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 102
Type of DeviceNONE
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1381549
Report Number1644487-2009-00990
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/15/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2010
Device MODEL Number102
Device LOT Number200943
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/07/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/15/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2008
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: 05/13/2009 Patient Sequence Number: 1
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