MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Scarring (2061)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.

Event Description

It was revealed during the investigation of the patient's recent explant due to infection, which was reported in mfg.Report #1644487-2019-02247, that the patient's previously implanted vns products were explanted due to infection at an unknown time.Follow up with the company representative revealed that the company representative presented to an office visit on approximately three months post-implant to assist the physician.The excerpt from the company representative's notes for the visit stated that the patient experienced slow healing wound post-implant and that there was a possible separation of internal stitches.It was stated that another physician assessed the wound.It was stated that the surgeon had arrived after the representative had already left the appointment and the assessment was unknown.The company representative was confirmed to be present at the vns re-implantation surgery of the most recent products, but was only provided with the patient's initials at this surgery and, therefore, did not know whether the patient was a new patient implant or previous vns patient at the time.It was stated that the patient had been fully draped in the or by the time the company representative had entered the or room and he could not assess whether the patient had a previous implant scar.A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution.No additional relevant information has been received to date.

Event Description

Follow up by the company representative revealed that there was no dehiscence wound and that the assessment of a possible separation of internal stitches was speculation on a potential cause of what was suspected/hoped to be a keloid from the surgery.The consulted surgeon hoped that it was a keloid at the site, but prescribed antibiotics prophylactically despite there being no redness, swelling, fever, or other signs of infection.The patient presented for a follow up a week later and it was found to be infected.The patient underwent explant surgery later that day and when the patient's incision was opened, pus was observed.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9350520
• MDR Text Key: 167335657
• Report Number: 1644487-2019-02260
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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: 09/30/2020
• Device Model Number: 106
• Device Lot Number: 204672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2018
• 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: 20 YR