MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Premature Discharge of Battery (1057); Output below Specifications (3004)

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

Event Date 05/19/2023

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 a generator was not functioning properly during a new implant procedure.The surgeon was using nim trivantage to monitor whether or not electrical stimulation was flowing the vagus nerve during intraoperative stimulation.This is an electromyograph (emg) tube.The nim did not respond, so the surgeon suspects a generator issue.Although encouraged to use an accessory kit to check the generator for any failures, the surgeon opted to unbox a new generator.System diagnostics were performed on this new generator, and results were good.The nim also received a normal response with the new battery, so it was implanted in the patient.Extended operating room time was about 15 minutes.The generator that was not implanted with a suspected malfunction was returned and received by the manufacturer to undergo product analysis.Analysis has not been completed to date.Generator device history record was reviewed and no unresolved non-conformances were found.The generator passed all quality control measures prior to distribution.No other relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.The alleged ¿energy output to patient tissue incorrect lower stimulation¿, ¿no stimulation" was not verified in the lab.Comprehensive electrical testing showed that the generator performed according to all functional specifications.However, a low temperature was noted prior to the date of attempted implant.It is known that low temperature can impact battery voltage.Therefore, the low battery voltage appears due to low storage temperature.No other anomalies were noted.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 17118424
• MDR Text Key: 317089622
• Report Number: 1644487-2023-00764
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106
• Device Lot Number: 7472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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: 38 YR
• Patient Sex: Female