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

Model Number 8103

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

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 that patient's device is believed to have prematurely depleted.The patient was seen to have really low battery life (ifi = yes) on (b)(6) 2022 visit.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Tablet data was received and reviewed.A premature depletion event has been identified.No obvious cause has been established, but a report of shoulder surgery being used in tandem with an abnormal voltage threshold value being seen in the data; electrocautery use during this shoulder surgery is probable, and the likely cause of the premature end of a life.This will not be considered the root cause until further confirmation is received.No other relevant information has been received to date.

Event Description

After further review of data, it was determined that the battery life begins to rebound, indicating that a beginning of life impedance issue was the cause of the reported premature end of life.However, with this conclusion, it can be determined that no true premature end of life is occurring.This event is related to an increased duration of the high battery impedance experienced by cfx batteries during the beginning of life (bol) or an internal short that managed to ¿burn¿ itself out.This is not considered a fault of the device.No other relevant information has been received to date.

• 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: 15971171
• MDR Text Key: 306810984
• Report Number: 1644487-2022-01601
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/19/2022; 01/23/2023
• Supplement Dates FDA Received: 01/13/2023; 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 33 YR
• Patient Sex: Male