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 Discomfort (2330); Weight Changes (2607); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.) h3.Code 81 - device evaluation is not necessary because the reported event has been determined as not related to vns therapy.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 that the patient is scheduled for a pocket revision.No reason for the surgery was provided.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Update was received that the patient lost a significant amount of weight after the implant, causing the generator to rotate significantly and the patient to feel pain; the pain was not resolved with reduction of vns settings.The surgeon is performing the revision for a better position of the generator.No other relevant information has been received to date.

Event Description

It was reported that patient had a pocket revision surgery for repositioning of both lead and generator due to migration of the devices.Lead migration is housed in mfr report #: 1644487-2023-01693.No other relevant information has been received to date.

Manufacturer Narrative

H6.Adverse event problem codes ¿ investigation conclusions; corrected data; supplemental mdr inadvertently omitted information known prior to submission.

Event Description

Response was received from the physician that the patient's weight loss is due to external factors.In addition the patient's pain was at the chest site and the surgical intervention was for patient comfort only.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17950101
• MDR Text Key: 325854972
• Report Number: 1644487-2023-01487
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2023

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: 05/13/2023
• Device Model Number: 8103
• Device Lot Number: 205597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/17/2023; 11/10/2023; 12/06/2023
• Supplement Dates FDA Received: 11/10/2023; 12/03/2023; 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2021
• 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; Other
• Patient Age: 27 YR
• Patient Sex: Female