MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE 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 12/28/2022

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 livanovas 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 patients battery reached 25% indicator prematurely.The device showed 18-25% battery life remaining after 7 months of therapy.Settings and diagnostics from two dates were provided.It was also reported that they are seeking replacement.Device history records were reviewed.The device passed all functional and quality testing prior to distribution.No recent surgeries, electrocautery, or unusual events occurred that could have contributed to the event.Tablet data was received and a decoder review was completed.There is suspicion that the voltage will rebound above the 2.85v 25% indicator threshold but not yet confirmed.Follow up has been initiated for updated system diagnostics.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Product analysis has been completed.A system diagnostics was later ran on 4/24 showing 75-100% battery and vbat calculated 2.976v.This indicates the battery voltage has rebounded above the 25% indicator and meets the limited investigation criteria for a historical data analysis investigation.The investigation looked into battery status indicators of 25% that were received sooner than expected and later returned to 100% without any significant programming changes.The investigation determined that the behavior was likely related to an increased duration of the high battery impedance experienced by batteries during the beginning of life (bol).The root cause of the premature battery depletion event is most likely related to bol battery impedance which is part of the device design, no device failure has occurred.No other relevant information has been received to date.

Event Description

It was reported that patient had a battery replacement.The explanted device has been received into product analysis which is underway but not yet completed.No other relevant information has been received to date.

• Brand Name: PULSE 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: 16353741
• MDR Text Key: 309313765
• Report Number: 1644487-2023-00163
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2023

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 Expiration Date: 10/06/2023
• Device Model Number: 8103
• Device Lot Number: 6995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 02/14/2023; 05/02/2023
• Supplement Dates FDA Received: 04/11/2023; 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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