MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

Model Number 303-20

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

Patient Problem Tissue Breakdown (2681)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the tissue breakdown is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported initially that the patient was referred for lead revision due to an unknown reason.It was later stated that the patient was referred for lead repositioning surgery and had been completed.The surgeon opened the patient's neck, corrected and added the strain relief loop to the lead and used new butterfly anchors from an opened accessory pack.The generator was turned off during surgery and the old settings were reapplied after surgery.No devices were replaced.The surgeon stated that it had seemed the anchor may have come off.Information was received from the surgeon per the notes for the surgery, stating there irritation by the anchor and partial skin erosion around the anchor itself, and the patient was complaining of neck tightness, reduced range of motion in the neck, and that's why he did the thus was the reason for the revision.The patient's surgery was for patient comfort reasons.No additional relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 11008079
• MDR Text Key: 221521353
• Report Number: 1644487-2020-01677
• 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: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2017
• Device Model Number: 303-20
• Device Lot Number: 3613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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 Age: 12 YR