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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Post Operative Wound Infection (2446)

Event Date 08/06/2015

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital with an infection.The patient had pus around the generator site.The patient had surgery on (b)(6) 2015 due to the superficial wound infection in the chest.The procedure included debridement of the dermis and subcutaneous layer.The operative notes reported that the patient presented in clinic on (b)(6) 2015 with appearance of the incision overlying the vagus nerve stimulator generator with the appearance of thinning as though it was at risk of dehiscing.The next day, the patient was admitted with evidence dehiscence that had started to begun and there was also some superficial spreading redness, which had the appearance of cellulitis.Surgery was performed as an emergency procedure, and during the procedure, the site was debrided and irrigated.The surgeon concluded that the evidence was favorable to suggest that the infection was cellulitis only with skin edge dehiscence.The patient was then closed.The generator was not explanted.Good faith attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

(b)(4).

Event Description

The patient later had generator explant surgery on (b)(6) 2015 due to an infected pocket.The explanted generator was received by the manufacturer for analysis.However, analysis has not been completed to date.Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.

Event Description

Analysis was completed on the generator.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

It was later reported on (b)(6) 2016 that the patient was scheduled to have her lead explanted that day due to an abscess in the neck area.Operative notes from (b)(6) 2016 report that the patient presented for ¿left cervical surgical skin site ulceration caused by erosion of underlying hardware¿ and plastic surgery for keloid formation around the previous generator site incision site.The indications for operation indicated that the generator was previously removed due to complication through the skin.Subsequently, that area of closure developed keloid and more an area in the center of the cervical incision site began to thin out and there was a palpable piece of hardware beneath that thinned out site.It worsened to the point skin broke through and there was a yellowish drainage that came from the site.This was cultured.The patient was admitted and was on iv antibiotics and brought to the room for the to remove the generator, the ulcerated and then have the plastic surgery service revise both the keloid incision and the lead incision on (b)(6) 2016.During the procedure, it was observed that the ulceration site was through dermis and through platysma.The area of the lead strain relief was eroding through the skin.Once that was excised out, the remaining tissues deeper appeared normal.It was irrigated with antibiotic irrigation and then the majority of lead was removed.For the remaining lead portion, it was assessed that it was not able to be easily extracted from within the carotid sheath.It was determined that this was unacceptably risky and difficult because of the extensive amount of scar tissue there/ what was at that point the only remaining wires with the thin final portions of the lead.It was felt that there was no deep infection.The deep space was verified to be sterile.The area was treated with the 3% hydrogen peroxide and after that irrigated it with bacitracin irrigation.The keloid at generator site was removed and there was additional debridement at the generator site.Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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 Key: 5111592
• MDR Text Key: 27052635
• Report Number: 1644487-2015-05960
• 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: Followup,Followup
• Report Date: 09/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2017
• Device Model Number: 103
• Device Lot Number: 203398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2015
• 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): Required Intervention
• Patient Age: 7 YR