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 Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/22/2023

Event Type  Injury  

Event Description

It was reported that the patient is experiencing pain and cramping.Device was noted to be disabled but the patient was still experiencing pain.Patient was noted to be referred for x-rays.Additional information was received noting that the surgeon suspects it may be a psychological issue and not a device problem.The neurologist notes that the patient still complained of feeling constant stimulation even when the device was programmed off.Device was explanted and patient reported prior to surgery of a loss in their voice with vns with a feeling that device was constantly stimulating.Explanted device has not been received to date.No other relevant information has been received to date.

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿voice alteration¿ is not available.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

Additional information from the physician was received noting that the cause of pain and voice alteration is due to vns stimulations.Cramping was also noted to be caused by vns stimulation but noted that disabling the device did not stop the cramping.Device disablement and referral for battery replacement was noted to be for patient comfort explanted device was received and is undergoing product analysis.

Event Description

Product analysis of the generator was completed.There were no performance, or any other type of adverse conditions found with the pulse generator.No other relevant information has been received 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17950493
• MDR Text Key: 325899288
• Report Number: 1644487-2023-01485
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 12/15/2023

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: 09/25/2021
• Device Model Number: 1000
• Device Lot Number: 205073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/24/2023; 12/11/2023
• Supplement Dates FDA Received: 11/16/2023; 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2019
• 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
• Patient Sex: Female