MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Failure to Interrogate (1332); Defective Component (2292)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

It was reported that the patient's generator could not be interrogated.It had been interrogated a few months prior with no issue.There were no known external influences or events that could have impacted the generator's function.Troubleshooting steps were taken to reduce electro-magnetic interference (emi), ensuring the wand is placed directly over the generator, checking wand power, replacing batteries if needed, verifying the wand selection on the tablet, and connecting with usb cable, all to no avail.The patient later underwent a battery replacement due to failure to program that was thought to be associated with a depleted battery.The explanted generator was returned to the manufacturer to undergo product analysis.Product analysis of the crystal from the returned pulse generator pcba was performed.The generator had communication issues when an interrogation and a system diagnostic test were performed, as received.However, the device did communicate the next day after leaving it overnight at the product analysis (pa) bench.Visual analysis of the device revealed that residues from the smt and battery attach process on multiple locations, including where the pcba crystal was located.The crystal was placed on a known, functional bench m106 generator pcba that communicates.This bench pcba was set to 3 volts but would not interrogate.This indicated that the crystal was not functional.It is also suspected that the heat to remove the crystal from the generator may have contributed to its final demise.Device history records were reviewed for the pulse generator.The device passed all specifications, including quality control inspection, and showed no non-conformities prior to its release into the field for distribution.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.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17773631
• MDR Text Key: 323728522
• Report Number: 1644487-2023-01353
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2023

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: 03/05/2023
• Device Model Number: 106
• Device Lot Number: 205511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Event Location: Other
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2021
• 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
• Patient Age: 12 YR
• Patient Sex: Female