MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

Model Number 303-20

Device Problem Positioning Problem (3009)

Patient Problems Irritation (1941); Swelling (2091); Neck Pain (2433); Fluid Discharge (2686)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had significant swelling at the electrode and generator sites.It was initially thought that the patient had an infection, but that was ruled out.The patient then had a nuclear medicine scan, which showed that the patient had lymphatic fluid in the soft tissue surrounding the electrode site and was leaking down to the chest pocket as well.The patient was feeling painful stimulation in the neck, which the physician attributed to the electrode site being irritated and swollen.It was determined that the fluid collection was due to the implant location of the electrodes.The physician performed lead revision surgery on (b)(6) 2016 to replace the lead and position the new electrodes in a different location on the nerve.The physician did not observe any fluid when he was performing the lead revision surgery.The explanted lead was received on (b)(6) 2016.Analysis was approved on (b)(6) 2016.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.Other typical wear and explant related observations, no anomalies were identified in the returned lead portion.

• Brand Name: LEAD MODEL 303
• 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: 5851977
• MDR Text Key: 51343817
• Report Number: 1644487-2016-01767
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/23/2018
• Device Model Number: 303-20
• Device Lot Number: 4065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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: 49 YR