MAUDE Adverse Event Report: LIVANOVA USA, INC. SYMMETRY GEN MODEL 8103; GENERATOR

Model Number 8103

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

Patient Problem Pneumonia (2011)

Event Date 04/06/2022

Event Type  Injury  

Event Description

It was reported that patient will have device explanted due to pneumonia.The patient's healthcare providers have suggested that she have the vns device removed due to aspiration challenges that the patient feels has increased ever since the vns device was implanted.No known relevant surgical intervention has occurred to date.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.

Event Description

It was later reported that the generator was explanted and received to undergo product analysis.Analysis has not been completed to date.No other relevant information has been received to date.

Event Description

Product analysis was performed on the returned generator.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.

Event Description

It was later reported that the patient¿s pneumonia is possibly related to the device, implant procedure, and device stimulation.The event has recovered/ resolved.

Event Description

Information was then received that the pneumonia is no longer reportable indicating that there is no indication that due to vns or allegation against vns.It was also indicated that the pneumonia was categorized as an unanticipated (serious)adverse event, although the event is documented in the manufacturer's labeling.

Event Description

Updated information was later received noting that the pneumonia was not an unanticipated adverse device effect.

• Brand Name: SYMMETRY GEN MODEL 8103
• 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: 15716046
• MDR Text Key: 302866390
• Report Number: 1644487-2022-01376
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/05/2023

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: 10/05/2023
• Device Model Number: 8103
• Device Lot Number: 205775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 02/14/2023; 03/17/2023; 04/26/2023; 06/12/2023; 08/11/2023
• Supplement Dates FDA Received: 03/09/2023; 04/11/2023; 05/19/2023; 07/07/2023; 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female