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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 08/01/2010
Event Type  Injury  
Event Description

It was reported that the patient's neck wound from vns implant had been experiencing drainage for approx four months and the wound was getting larger. It was indicated that there was granulation tissue at the medial aspect of the wound that was cauterized using silver nitrate. A portion of the lead was visible within the granulation. The physician also prescribed bacitracin to treat the wound dehiscence. It was later found that the wound was likely a stitch abscess. This was removed and the wound was cleaned. The vns lead was not removed. Attempts for further info are in progress.

 
Manufacturer Narrative

Device history 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
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1993841
Report Number1644487-2011-00254
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2010
Device MODEL Number302-20
Device LOT Number200487
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/12/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2007
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: 02/11/2011 Patient Sequence Number: 1
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