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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Sepsis (2067); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 02/13/2023

Event Type  Injury  

Event Description

It was reported that patient had swelling at generator site, and had a computed tomography (ct) scan done.Following the scan, the patient was acting strange and brought into the emergency room.It was determined the patient was septic due to an infection at the implant site, and he was admitted to the hospital.The sepsis is believed to be related to the vns implant.Since patient's admittance to the hospital, the device could be seen through the open wound.The patient was later diagnosed with pneumonia, and they have a dropping heart rate issue.The patient then had their vns removed.Device history records were reviewed for the generator and lead.The generator and lead passed all specifications prior to distribution.The generator and lead were hp sterilized.Suspect product has not been received by manufacturer to date.No other relevant information has been received to date.

Manufacturer Narrative

Device evaluation is not necessary as the reported events of sepsis and infection are not related to the functionality or delivery of therapy of the device.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.Health effect - clinical code :e0733.Health effect - clinical code :e1713.Health effect - clinical code :e1719.

• 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: 16628573
• MDR Text Key: 312137637
• Report Number: 1644487-2023-00359
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/08/2023
• Device Model Number: 106
• Device Lot Number: 7065
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2022
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male