MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 09/22/2023

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 error code 34 was seen upon interrogation.Error code 34 is indicative of an unexpected generator reset due to an unknown reason.Device history records were reviewed.The device passed all functional specifications and quality tests and were sterilized prior to distribution.Per the rep, the neurosurgeon in or reportedly had some difficulties with the communication between the tablet and the wand.The error code 34 showed once.She changed new batteries and pressed the power button for more than 10 seconds and cleared the screen.After that everything was fine, and she finished the implantation.The generator worked perfectly.No other relevant information has been received to date.

Event Description

Additional information was received reporting that error code 34 did not occur.A review of the data was completed by the quality engineering team.There were also some difficulties with communication between the tablet and the wand.When batteries were changed and power button was pressed for more than 10 seconds, communication re-established and the generator worked well.Decoder data and data logs were reviewed for error code 34.Error code 34 was not seen in the data log file.However, error code 109 was seen which indicates that there was loss of connection for wand.A error message 128 was seen after that which may be due to emi or wand positioning.The communication error was fixed by pressing the power button of the programmer for more than 10 seconds to clear screen and replacing the batteries for wand as recommended by troubleshooting guide.Additionally, with the review of decoder and log files it can be confirmed that there is no issues with generator itself.No other relevant information has been received to date.

Manufacturer Narrative

H6: investigation findings: the initial reporter inadvertently left out a relevant code.H6: investigation conclusions: the initial reporter inadvertently used the incorrect code.

• Brand Name: PULSE GEN MODEL 1000
• 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: 17980993
• MDR Text Key: 326259203
• Report Number: 1644487-2023-01517
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000
• Device Lot Number: 206050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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: 40 YR