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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 04/19/2011
Event Type  Injury  
Event Description

Reporter indicated a vns pt has a wound dehiscence "dimple" at the electrode site incision in the neck. No drainage or infection was present, and no hardware was visible in the wound. The pt had no trauma and did not manipulate the vns. The pt was placed on keflex antibiotics along with topical bacitracin antibiotic. The pt was seen again on (b)(6) 2011 and is stable; "no better, no worse. " topical bacitracin treatment is to continue, and the pt has been referred back to the care of his neurologist. The cause of the wound dehiscence is unk.

 
Manufacturer Narrative

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

 
Event Description

Reporter indicated, the patient had lead repositioning surgery performed on (b)(6) 2011. Diagnostics were within normal limits and the vns generator was reprogrammed to intended settings.

 
Event Description

Reporter indicated a patient was to have possible scar revision surgery at the vns lead incision site in the neck due to possible scar tissue encasing the lead and causing neck pain with movement. The patient previously had wound dehiscence at the neck incision in (b)(6) 2011. Surgery is tentatively planned for (b)(6) 2011.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2100482
Report Number1644487-2011-01104
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/19/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number302-20
Device LOT Number200644
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/16/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2007
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: 05/17/2011 Patient Sequence Number: 1
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