MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Dyspnea (1816); Muscle Spasm(s) (1966); Neck Pain (2433)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

Patient problem :(b)(6).

Event Description

It was reported that a vns patient who is still in titration began to experience dyspnea upon exertion when the vns output current was increased.The patient was implanted one month prior, and they stated they may be titrating too fast for her.The patient later reported to the company representative that she was experiencing pain in the neck area of vns.She stated that if the pain continued she was going to tape the magnet down to see if it helped with the pain.Information was later received that follow-up was received providing that the physician had lowered the frequency setting.The patient¿s pain subsided however it still "bothers" her voice.The physician wants to increase the current but tolerability for the patient had been an issue.Additional relevant information has not been received to-date.

Event Description

Follow-up on 05/30/2018 provided that the physician wants to make changes to improve the side effects.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7537765
• MDR Text Key: 109041581
• Report Number: 1644487-2018-00849
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/21/2018
• Device Model Number: 106
• Device Lot Number: 5099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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): Required Intervention
• Patient Age: 21 YR