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); Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/02/2023

Event Type  Injury  

Event Description

It was reported that immediately after the patient was implanted they had worsening voice alteration, increased difficulty swallowing, chills and shortness of breath and went to the emergency room.The patient was later hospitalized that same day due to a diagnosis of pneumonia.Additionally it was noted that the patient suffered from a vagal nerve injury that as resulted in vocal cord paralysis.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.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿chills¿ 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.Health effect - clinical code :e012202; health effect - clinical code :e2402; health effect - clinical code :e0733.

Event Description

Additional information was received reporting bilateral hearing loss and tissue damage from surgery no other relevant information has been received to date.

Manufacturer Narrative

A2 age at the time of event, corrected data - the initial reporter inadvertently used the wrong age for the patient.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿tissue damage¿ is not available.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿bilateral hearing loss¿ is not available.F10 health effect, clinical code, corrected data: the initial reporter inadvertently used e2402 for & voice alteration which was already captured in an existing code already used and did not need to be used.

• 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: 18252316
• MDR Text Key: 329556253
• Report Number: 1644487-2023-01673
• 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: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1000
• Device Lot Number: 206003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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; Disability; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female