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 Neck Pain (2433); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/20/2023

Event Type  Injury  

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 ¿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.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined as not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient's device has migrated leftward near their armpit and they have a taut lead wire.The events are noted to be definitely related to the implant procedure.The patient has since been referred for a revision surgery.Device history record review for the generator performed.The generator passed final functional and quality specifications prior to release for distribution.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B5 describe event or problem, corrected data: initial report inadvertently left out relevant information d6b if explanted, give date (mo/day/yr), corrected data: initial report inadvertently did not provide the explant date f10 adverse event problem, corrected data: initial report inadvertently left out code 'f1905' h6 adverse event problem, corrected data: initial report inadvertently coded 'b17' for type of investigation.

Event Description

Additional information received noting that the patient underwent a pocket revision to reposition the generator.While in the surgery, the generator was hit with electrocautery causing the battery to deplete.The patient ended up undergoing a battery replacement.

Manufacturer Narrative

B5 describe event or problem, corrected data: supplemental #01 report inadvertently did not note that the device was received d9 device available for evaluation?, corrected data: supplemental #01 report inadvertently left blank h3 device evaluated by mfr?, corrected data: supplemental #01 report inadvertently left blank.

Event Description

The explanted generator was received and product analysis is underway.

Event Description

Product analysis was completed on the returned generator.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant which may have been a contributing factor for the pulse disabled event.Other than the noted event (pulse disabled), there were no additional performance, or any other type of adverse conditions found with the pulse generator.

• 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: 18030734
• MDR Text Key: 326863861
• Report Number: 1644487-2023-01562
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2024

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 Model Number: 8103
• Device Lot Number: 7415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 01/12/2024; 01/23/2024
• Supplement Dates FDA Received: 12/05/2023; 01/12/2024; 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2022
• 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
• Patient Age: 40 YR
• Patient Sex: Female