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 Weight Changes (2607); No Code Available (3191)

Event Date 02/15/2017

Event Type  Injury  

Event Description

It was reported to a company representative by a surgeon¿s office that a vns patient wants to have her vns removed.Follow-up to the treating neurologist¿s office provided the patient was last seen on (b)(6) 2016 and requested that device be turned off due to perceived weight loss.The neurologist turned off the device at that time and told the patient to contact the surgeon if she wanted it removed.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Clinic notes were received for surgical referral providing the patient reports it won¿t allow her to gain weight.

Event Description

The patient was referred for replacement due to decreased appetite and weight loss.The neurologist did not know if the decreased appetite and weight loss was related to stimulation or presence of the device.Programming history was reviewed and no programming anomalies were seen.Surgery is likely but has not occurred to date.No additional or relevant information has been received.

• 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: 6405006
• MDR Text Key: 69945572
• Report Number: 1644487-2017-03384
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: 106
• Device Lot Number: 3382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2016
• 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: 31 YR