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 Chest Pain (1776); Seizures (2063); No Code Available (3191)

Event Date 01/25/2019

Event Type  malfunction  

Event Description

The patient reported that they have had a recent increase in seizures, and they also wanted to know if the vns generator could move.The patient noted that there are no causal factors for suspected generator migration and increased seizures.No other relevant information has been received to date.

Event Description

It was reported via clinic notes that the patient felt a sensation as if the vns device was moving in her chest and that a chest x-ray was performed that indicated slight rotation of the device.The patient also reported a symptom of feeling a "tugging" on her vns generator.The patient reported a tugging feeling and felt as though the generator was out of place.Clinic notes also reported that the patient responded well to the vagal nerve stimulator magnet.No further relevant information has been received to date.

Event Description

It was reported that the patient was referred for replacement due to generator migration.Clinic notes indicated that the patient felt a sensation as if the vns device moved in her chest and that their surgeon had determined not to reposition the device.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The surgeon confirmed that the patient's generator was not secured with a non-absorbable suture at implant.No other relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8372209
• MDR Text Key: 137243589
• Report Number: 1644487-2019-00340
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2018
• Device Model Number: 106
• Device Lot Number: 5096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2016
• 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 Age: 49 YR