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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303-20

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CYBERONICS, INC. LEAD MODEL 303-20 Back to Search Results
Model Number 303-20
Event Date 08/01/2012
Event Type  Injury  
Event Description

Reporter indicated a patient developed an infection at the vns lead site in the neck. The patient was given antibiotics. Exploratory surgery of the infection site was planned for (b)(6) 2012, but it is not known if this occurred. Attempts for further information are in progress.

Manufacturer Narrative

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

Event Description

Reporter indicated the patient had debridement surgery with washout performed on (b)(6) 2012. The two lead tie-downs were removed, as the tie-downs were felt to possibly be causing an allergic reaction which is believed to have caused the infection. The tie-down areas were purulent and irritated. The lead body (not electrodes) was repositioned in a different area away from the infected area. The vns was left programmed on. The patient had no known trauma, and the patient is healing well. Wound cultures were performed which grew out (b)(6) bacteria.

Event Description

The patient's mother reported that the electrode was extruding through the patient's neck. It was reported that the patient was prescribed antibiotics and the patient was scheduled for revision surgery. Clinic notes date (b)(6) 2013 note that the patient forms keloids and has experienced chronic crusting from the site. It was noted that the patient was seen with yellowish discharge from the wound site. It was noted that the wound was not erythematous or swollen. The notes indicate that the wound has a keloid and induration, but is not red. A small area of crusting with no exudate was noted. The patient was sent home with bactrim. Operation notes dated (b)(6) 2012 note that the surgical findings were exposed vagal nerve stimulation tie-down tabs with surrounding inflamed skin and extensive subcutaneous granulation tissue surrounding the deeper tie-down tabs and superficial connecting lead, but no evidence of pus. Clinic notes dated (b)(6) 2013 note that the wound showed a chronic ulceration with exposed connecting lead through the wound. There was no drainage or evidence of infection, although there has been crusting and scabbing along the wound. The patient denies picking at the wound. The patient was seen at the emergency department on (b)(6) 2013 after the wound opened up and was sent home with bactrim. The patient denies any trauma to the area. There is no evidence of drainage. The wound is non erythematous and non tender. The notes indicate that the surgeon is going to try one more time to treat the device in situ with antibiotics solution as well as iv antibiotics. It was noted that if it fails explant will be performed. Operative notes dated (b)(6) 2013 note that the vagal nerve stimulator electrode connecting lead in the anterior cervical region is exposed and there is surrounding inflamed skin and subcutaneous granulation tissue, but no evidence of pus. The wound was debrided and a complex closure was performed. Excision of devitalized granulomatous skin was performed. The notes indicate that the mother reported that the scab had fallen off and the lead wire was exposed; therefore treatment in situ was performed. Multiple antibiotic solutions including vancomycin irrigation, half-strength hydrogen peroxide, lactated ringer's bacitracin solution and also vancomycin crystals were attempted to treat the infection and prevent recurrence. The notes indicate that it is almost as if the patient is rejecting the device. On (b)(6) 2013 it was reported that the patient came in with exposed vns generator and is getting it replaced emergently. The following day it was reported that the surgeon debrided the pocket and that there were no issues with the lead. The surgeon placed prophylactic antibiotics in the pocket and lead area. A new generator pocket was formed and the new generator was placed under the muscle to avoid patient manipulation. The patient was given a picc line for antibiotic. It was reported that if the infection persists the patient may be explanted due to body rejection. The patient's mother believes that the patient's bra underwire may have contributed to the issues initially. Operative notes dated (b)(6) 2013 note that the left anterior chest pocket is infection in the generator area due to skin breakdown and protruding generator. It was noted that the generator pocket had accumulation of purulent fluid likely related to a pinhole sized are of skin breakdown most likely related to rubbing of this area from the patient's underwire bra. It was noted that skin cultures were positive for staphylococcus aureus. The explanted generator was received for analysis. Analysis of the generator was completed on (b)(6) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

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Brand NameLEAD MODEL 303-20
Type of DeviceLEAD MODEL 303-20
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2768901
Report Number1644487-2012-02492
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2014
Device MODEL Number303-20
Device LOT Number2639
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/18/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/16/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/20/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 10/02/2012 Patient Sequence Number: 1