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 Edema (1820); Pain (1994); Neck Pain (2433)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported that they experienced pain and swelling in their neck that started about two months prior to the report.The patient described the pain as a pulling sensation and knotting in the neck.Per the patient, the neurologist mentioned that the stimulation is irritating the patient's muscles, but referred the patient to the surgeon for a consult.Further follow up with the neurologist's office confirmed that the cause of the neck pain and swelling was due to the device migrating to the right side.The patient has been referred to the surgeon for further assessment.Per the physician, the referral for surgery is for both patient comfort reasons and to preclude serious injury.It was mentioned that this is all the information that the physician's office has at this point in time.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that the patient's generator was replaced due to the patient complaint of shocking sensation with discomfort 2-3 times per day in his neck area.He also stated he had limited range of motion in his left neck area from vns lead.The generator was in the right chest not the left.The explanted product was received but analysis on the device has not been completed to date.No further relevant information has been received to date.No known further relevant surgical intervention has occurred to date.

Event Description

Product analysis was completed on the returned generator.The generator was monitored for 24 hours in a simulated body temperature environment.The generator provided the intended output current for the entirety of the monitoring period.A comprehensive electrical evaluation showed that the device performed according to functional specifications.No anomalies were identified.No further 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: 8756469
• MDR Text Key: 149912927
• Report Number: 1644487-2019-01271
• 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
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/16/2018
• Device Model Number: 106
• Device Lot Number: 4903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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: 67 YR