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 Problems Hemorrhage/Bleeding (1888); Depression (2361)

Event Date 06/23/2022

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 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 reported by the patient they emergency vascular surgery due to hemorrhaging post implant.The patient was discharged a few days after and incision was bigger than the original due to the emergency surgery.Clinical study also reported the event as post-surgical bleeding and was considered a serious event.The event was indicated to be related to the implant procedure and event had recovered/resolved.No additional relevant information has been received to date.

Event Description

It was later reported that patient was experiencing increased depression and sadness.The event is noted to be possibly related to the implant procedure.The outcome is not resolved/not recovered.

Event Description

It was later reported that the event of post-surgical bleeding has been updated to damage to vein/artery.The events required hospitalization and it was a life-threatening illness or injury.The patient had a neck artery repair surgery.The patient has recovered from these events.No additional relevant information has been received to date.

Event Description

It was later reported patient experienced pain (inside) underneath & surrounding vns device.The event is reported to be mild, probably related to the device and not recovered/not resolved.There was no action taken for this event and there was no change in medication.The event is ongoing.No additional relevant information has been received to date.

Event Description

Clinical study later reported that the event of post-surgical bleeding is no longer deemed reportable for the study.

Event Description

Clinical study later clarified that the event of post-surgical bleeding is actually reportable for the study.It was previously deemed no longer reportable in error.

• 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: 15085842
• MDR Text Key: 296404748
• Report Number: 1644487-2022-00884
• 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: 06/20/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/06/2023
• Device Model Number: 8103
• Device Lot Number: 6995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 07/25/2022; 10/13/2022; 11/11/2022; 04/26/2023; 05/26/2023
• Supplement Dates FDA Received: 08/17/2022; 11/07/2022; 12/06/2022; 05/19/2023; 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male