MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Tissue Breakdown (2681)

Event Date 10/01/2017

Event Type  Injury  

Event Description

It was reported that the patient was experiencing swelling in the neck.The physician was unsure if it was related to vns and referred the patient for x-rays in order to further assess the swelling.The swelling was reported as constant and unrelated to stimulation.The lead impedance was reported as within normal limits.Follow up with the physician revealed that there was no trauma or patient manipulation to the area.The physician did not think the swelling was related to the vns, but due to the asymmetry of the swelling, which was only on the vns side of the neck, they were unable to rule it out.The swelling was not associated with stimulation.There was no interventions planned or taken at that time.It was later reported that the patient's neck swelling had gone down and the patient was asymptomatic with no pain or discomfort.X-ray images were received by the manufacturer and reviewed.The lead visibility varies throughout the length of the lead visible in the provided images as only the neck x-rays were provided.The review was unable to assess if strain relief was present and placed according to labeling due to the unorganized placement of the lead in the neck.The review was able to identify only one tie-down.No apparent sharp angles or gross fractures were identified in the visible portions of the lead.The patient's previous lead could be observed in the image.Based on the x-rays received, the cause for the swelling cannot be determined.It was later reported that the patient was complaining of something not being right.The patient the proceeded to pull a two inch piece of the remaining lead left over from the previous lead revision.The patient believed it was an ingrown hair and pulled it out with tweezers.It was stated that it came out without pain and that the patient has not had further issues.The medical professional believed that the previous edema was caused by the remaining portion of the previous lead.No additional relevant information has been received to date.

Event Description

Follow up with the company representative revealed that the extracted lead portion had been discarded.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7740319
• MDR Text Key: 115723631
• Report Number: 1644487-2018-01317
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2010
• Device Model Number: 302-20
• Device Lot Number: 200471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/03/2018
• Supplement Dates FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR