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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

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CYBERONICS LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 10/20/2010
Event Type  Injury  
Event Description

It was reported that the vns patient developed an infection and dehiscence due to patient manipulation of the lead site which caused the lead to extrude from the patient¿s skin. The patient underwent surgery on (b)(6) 2011 to explant the generator and lead. Follow-up revealed that the patient¿s incision site had never fully healed. The patient previously underwent surgery on (b)(6) 2010 to revise the incision site. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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 NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4442128
Report Number1644487-2015-03682
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2015
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 Number200646
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/25/2007
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: 01/22/2015 Patient Sequence Number: 1
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