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 Dysphagia/ Odynophagia (1815); Headache (1880); Paresis (1998); Suicidal Ideation (4429); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/17/2023

Event Type  Injury  

Event Description

The patient reported experiencing trouble digesting food, no gag reflex, throat pain, headaches, stomach bloating, emesis, groin pain, nausea and choking sensation and related all events to the vns.The patient's settings were lowered but this did not resolve the symptoms.The patient reported suicidal ideations in the past due to the adverse events they experienced.The patient's device was checked and all values were within normal limits.The patient's device was then disabled and they were referred for an eeg.No other relevant information has been received to date.

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.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿dyspepsia ¿ is not available.Health effect - clinical code :e1032.Health effect - clinical code :e1020.Health effect - clinical code :e2311.Health effect - clinical code :e2311.Health effect - clinical code :e2402.

Event Description

Additional information received noting that the patient was seen by a physician who diagnosed him with gastroparesis.The patient also reported that they have developed a stomach infection.The patient noted they were hospitalized.No other relevant information has been received to date.

Manufacturer Narrative

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

• 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: 18289079
• MDR Text Key: 329992802
• Report Number: 1644487-2023-01765
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2022
• Device Model Number: 1000
• Device Lot Number: 205163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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): Other; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male