MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Wound Dehiscence (1154); Cellulitis (1768); Edema (1820); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Sepsis (2067); Tachycardia (2095); Chills (2191); No Code Available (3191)

Event Date 04/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient that was recently implanted with vns was hospitalized due to an infection that required removal of the vns system.Clinic and operative notes were received on 04/21/2016 regarding the patient's infection.The patient had vns implant surgery on (b)(6) 2016 and was admitted to the hospital on (b)(6) 2016 due to nausea, chills, pain at the neck and chest incisions, odynophagia, and pain while moving her neck.The patient started having drainage at the neck area.After the patient was admitted to the hospital, it was determined that the patient had fever, tachycardia, and leukocytosis.There was evidence of inflammatory changes/edema in soft tissue of the left check and neck.The patient was diagnosed with sepsis secondary to left chest wall cellulitis.The patient's vns system was explanted on (b)(6) 2016 due to the infection.The patient was treated with antibiotics for a streptococcus pyogenes (group a).The patient was admitted to the hospital for surgery on (b)(6) 2016 due to "issues" with her incision.The patient was experiencing wound dehiscence at her neck incision after her vns system was explanted.Irrigation and debridement of the cervical wound and a revision of the wound was performed.It was not known if the wound dehiscence was a continuation of the previous infection, but it was stated that it could have been due to possible poor wound healing.The device history records of the lead and generator were reviewed, and both were sterilized according to procedure prior to release.

Event Description

Ct scans performed during the patient's visit on (b)(6) 2016 were provided on (b)(6) 2016.The indication for the ct scan was recent removal of implant for seizures with draining incision in the neck.The ct of the chest identified focal induration within the left breast which was nonspecific.There was no pathologically enlarged adenopathy or mass.In the neck.There was no evidence of discrete fluid collection or mass.The ct of the neck identified a small air-filled cavity in the anterior aspect of the neck along the medial aspect of the left sternocleidomastoid muscle.There was no discrete fluid collection to suggest abscess.The patient also had a picc line placed from the right arm for the infection.

• Brand Name: PULSE GEN MODEL 106
• 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: 5655090
• MDR Text Key: 45198615
• Report Number: 1644487-2016-01017
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

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: 03/03/2018
• Device Model Number: 106
• Device Lot Number: 4775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 26 YR