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

Model Number 106

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that during a following up, when interrogating the generator error code 10 (burst watchdog timeout) was observed.It was noted that the autostim was off.Tablet data was also provided for review.The provider also added that the patient was not exposed to any high energy fields, did not undergo any recent medical procedures, and did not experienced any environmental changes that may impact the ipg.A burst watchdog timeout reset is a risk mitigation to ensure the therapy (on time) is not delivered for the longer duration and intended to cover unexpected scenarios.Potential causes of burst watchdog timeout for this device could be a memory error (which could not be detected as the failure signature is not recorded in the file) or a possible firmware bug.The generator data decoder confirms that the burst watchdog timeout was encountered when the device was interrogated.According to the data, therapy was reenabled following the timeout error and system diagnostics were within normal limits after event.No other relevant information has been received to date.

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

Update was received that the generator was interrogated and a therapy disabled message was seen again; therapy was re-enabled.It was noted that the patient has another device within close proximity of the vns.Additional tablet data was received for review.From review of the decoder, burst watchdog timeouts were seen two additional times.The patient was able to have therapy enabled again and diagnostics were within normal limits after the events.No other 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18124509
• MDR Text Key: 328631616
• Report Number: 1644487-2023-01629
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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: 106
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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: 20 YR
• Patient Sex: Male