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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 09/21/2010
Event Type  Injury  
Event Description

A vns surgeon's office reported to our country representative in (b)(6) that they had a vns pt who developed a postoperative infection at the generator incision site with wound dehiscence and had their vns generator explanted. The pt's infection is being attributed to their implantation of the vns. No pt trauma or manipulation of their vns site was reported prior to their infection. Their infection has since resolved and the pt will be getting another implantation of the vns.

 
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 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1905623
Report Number1644487-2010-02614
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2011
Device MODEL Number103
Device LOT Number2542
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/22/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2010
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: 11/19/2010 Patient Sequence Number: 1
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