MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Scar Tissue (2060); Neck Pain (2433); Cramp(s) /Muscle Spasm(s) (4521); Skin Infection (4544)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that patient was experiencing "pulses" that are also visible sometimes.The patient's neurologist believes that tension relief was not put in place.Patient has been referred for possible stain relief revision.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information was received that the pulses were specified to be abnormal sensations and were felt in the patient¿s neck.Intervention was taken to preclude further injury for the patient.No further relevant information has been received to date.

Event Description

The patient was referred for vns lead repositioning vs replacement.It is mention that the patient she was moving at the time right after her implantation and did not follow her post-operative instructions and had a lot of lifting and bending and twisting and caused incision to open somewhat.She had significant scarring in her chest pocket incision as well as scarring along the lead in the left side of the neck which she reports is constantly pulling and causing discomfort.She says when it discharges it is quite painful.Primarily it is the pulling and scarring that bothers her the most, otherwise she has no fever or chills , no current symptoms of any sort of infections.Notes then state the patient has scar tissue over both the generator and lead due to infection and significant motion after implantation.No known surgical intervention has occurred to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15413920
• MDR Text Key: 299809756
• Report Number: 1644487-2022-01136
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 00542502575040
• UDI-Public: 0542502575040
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2022
• Device Model Number: 1000
• Device Lot Number: 205396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 09/21/2022; 12/06/2022
• Supplement Dates FDA Received: 10/14/2022; 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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: 28 YR
• Patient Sex: Female