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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 03/24/2014
Event Type  Injury  
Event Description

It was reported that the recently implanted vns patient¿s incision sites were red and swollen about 2-4 weeks after implant surgery so the patient was given an antibiotic regiment. The patient¿s lead was reported to be extruding from her neck. It was noted that the patient may have been picking at her neck incision site following implant surgery. Clinic notes were received indicating that the patient had a grand mal seizure that lasted several minutes and subsequently caused her lead the extrude from the left side of her neck. The patient went to the emergency room on (b)(6) 2014 and was admitted to the hospital due to lead extrusion. The patient did not have a fever or any neck swelling. There was no change in the patient¿s seizure frequency. The lead was observed to be extruding from the neck incision site with minimal erythema. The patient¿s chest had a puffy area that was fluctuant but not especially erythematous with no surrounding induration. The surgeon stated that it was most consistent with a seroma with a possible foreign body reaction. The patient underwent surgery on (b)(6) 2014 to explant her generator and revise the lead. Operative notes indicate that there was a mass of inflammatory tissue in the chest wall upon opening the epithelium. An exuberant amount of inflammatory tissue was observed around the patient¿s generator. No abscess was encountered. Other than granulation tissue in the left neck, the lead incision site looked normal and without any sign of infection. A portion of an electrode and a tie-down were observed to be extruding from the neck. The tie-down was removed from the lead. The patient¿s device was tested and diagnostic results revealed lead impedance within normal limits. The inflammatory tissue in the chest wall was removed and the patient¿s generator was explanted. The surgeon explanted the generator because he felt it was too big to be sterilized in the contaminated generator site. The generator pocket was debrided and rinsed with an antibiotic solution. The neck incision was then reopened and the granulation tissue was removed. The surgeon pulled down the disconnected lead in the chest wall and was able to reposition the lead into the deep intramuscular tissues in the neck. The neck incision site was irrigated and then closed. Antibiotic ointment was applied to the neck incision site. The lead was secured in the chest wall with sutures and the chest incision was closed. The patient was given a postoperative antibiotic regiment. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted generator was returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the returned generator was completed. Results of diagnostic testing indicated the device operated and communicated properly. 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.

 
Manufacturer Narrative

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

 
Event Description

It was reported that the patient had another surgery about three months after the generator explant to have her leads explanted due to foreign body reaction in the left neck and upper left chest. The surgeon removed an inflammatory mass of in the left chest cavity (4cm). No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
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 Key3827886
Report Number1644487-2014-01344
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup
Report Date 05/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2017
Device MODEL Number304-20
Device LOT Number202695
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/29/2013
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: 05/22/2014 Patient Sequence Number: 1
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