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

Model Number 304-20

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

Patient Problem Unspecified Infection (1930)

Event Date 10/26/2016

Event Type  Injury  

Event Description

The patient underwent a tracheostomy during a hospitalization for kidney stones.During the tracheostomy procedure the vns lead became exposed.The wound was left open and the medical staff was attempting to keep it covered.It was later reported that the wound was still open and the physician intended to take action to close the wound.However no surgical interventions were reported to occur at that time.Several months later it was reported that the patient was being referred for explant due to infection.No surgical interventions.A review of the manufacturing records for the lead and generator confirmed that both were sterilized prior to distribution.No additional relevant information has been received to date.

Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

Event Description

It was reported that the vns lead and generator were explanted to allow for the patient to recover from the infection.However the date of the surgery is not known.No additional relevant information has been received to date.

Event Description

It was reported that the wound closure surgery had never occurred because the patient was not deemed healthy enough to undergo a surgery where an already exposed implantable device was to be potentially retained.The physician believed that the exposed vns device led to the subsequent infection which led to the devices explant.It was noted that the infection was occurring along the implanted device and especially centered around the vns generator.

Manufacturer Narrative

Corrected data: evaluation codes; (b)(4).This information was inadvertently left off on mfg.Report #2.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 6520738
• MDR Text Key: 73664486
• Report Number: 1644487-2017-03675
• 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,Followup,Followup
• Report Date: 06/18/2017

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: 07/31/2018
• Device Model Number: 304-20
• Device Lot Number: 203077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/19/2017; 06/18/2017; 06/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2014
• 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: 60 YR