MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

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

Patient Problems Nerve Damage (1979); Paralysis (1997); No Code Available (3191)

Event Date 08/03/2017

Event Type  Injury  

Event Description

The physician reported that a patient suffered vocal cord paralysis following a previous lead revision surgery.The physician noted that the patient ended up having a device implanted to help their voice, and informed that the vns was turned off for several months following the vocal cord paralysis onset.The physician has recently programmed the vns back on to very low settings.The physician attributed the vocal cord paralysis to the vns lead revision surgery, noting that the patient's nerve was possibly nicked during the procedure.No other relevant information has been received to date.

Event Description

It was reported that the patient's vns device has been disabled as the patent was still not able to tolerate vns after their vocal cord issues.It was reported that the patient was coughing with the vns stimulation, and although the diagnostics were ok, the patient's vns was disabled.The patient has been advised to follow up with the surgeon for evaluation.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8471259
• MDR Text Key: 140545761
• Report Number: 1644487-2019-00600
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: 304-20
• Device Lot Number: 5118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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: 35 YR