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

Model Number 1000

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2022

Event Type  malfunction  

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 livanovas 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

Patients mom reported that since the patients first titration, the patient has been having some mild voice alteration that happened every 5 minutes with stimulation.Four hours after the last titration, she was no longer having any voice alteration with stimulation including magnet stimulations.During programming history review, it was later discovered that this generator experienced an unexpected reset around the time of patient not experiencing voice alteration.Device history records were reviewed for the generator.The device passed all functional specifications and quality tests and no nonconformance was observed.The generator part number indicates this device contains the updated firmware for the gc5 reset issue.Decoder review for the generator was performed.It indicated that an error code 6 was noted on the date of clinic visit.All impedance values were within normal limits.No other relevant information has been received to date.

Event Description

It was later reported that patient had full revision due to high impedance and migration.The suspect product has been received by manufacturer.Analysis has not been completed to date.This mdr houses the report of reset on the generator.Mfr ref #: (b)(4).Houses the report of high impedance and migration.Explant coding will be captured in this file, as the reason for explant was high impedance and migration, not the generator reset.

Event Description

Product analysis the suspect generator was completed.The visual observations are most likely associated with manipulation of the device during the implant/explant procedures.An interrogation and a system diagnostic test were performed.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation was performed.No anomalies were seen, and the device performed according to functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.Internal generator data confirmed a reset occurred on previously reported 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: 16618535
• MDR Text Key: 312057939
• Report Number: 1644487-2023-00361
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2023
• Device Model Number: 1000
• Device Lot Number: 205632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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: 29 YR
• Patient Sex: Female