MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Discomfort (2330); Weight Changes (2607); Unspecified Respiratory Problem (4464)

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

It was reported that patient had difficulty speaking, pain, coughing up blood, weight loss, and a seizure which caused him to be admitted to the hospital.Patient also believes that the device had caused nerve damage.The device was noted to be disabled after being admitted, and dr.Stated the device was defective and should be removed.Patient is noted to be on maximum output current.Patient was then sent to neurology center, where they had stated they will not remove his device.Patient threatened legal action against the neurology clinic due to this.The reported seizure is not deemed to be an increase and will not be captured within this report.The report of nerve damage has not been verified by a medical professional and will be encompassed under the reported pain.No known relevant surgical intervention has occurred to date.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14733868
• MDR Text Key: 294279830
• Report Number: 1644487-2022-00715
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2022

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: 04/10/2021
• Device Model Number: 106
• Device Lot Number: 204980
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male