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 Problems Hemorrhage/Bleeding (1888); Scarring (2061)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the reported events of bleeding and scarring are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that during a patient's vns replacement surgery, there was "significant" bleeding caused by heavy scarring of the vagus to internal jugular vein.Due to the bleeding the surgeon considered re-implanting on the right vagus nerve; however, the bleeding was controlled and the physician implanted on the left vagus nerve.The patient historically twisted and manipulated their lead.Device evaluation is not necessary because the reported events of significant bleeding and scarring are not related to the functionality or delivery of therapy of the device.No further relevant information has been received to date.

Event Description

Follow up with the surgeon's office revealed that the bleeding was mild to moderate during initial dissection.It was stated that this eventually required intervention by vascular service and was successfully addressed with no residual adverse effects.It was stated that the physician's assessment on the root cause of the heavy scarring was related to the patient's body habitus, to the previous procedure, and to possibly unknown genetic factors.

• 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: 9535572
• MDR Text Key: 173450737
• Report Number: 1644487-2019-02531
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• 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,Followup
• Report Date: 02/10/2020

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: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: 303-20
• Device Lot Number: 6154
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2019
• 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): Other
• Patient Age: 17 YR