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

Model Number 106

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

Patient Problems Pneumonia (2011); Status Epilepticus (4408); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  Death  

Event Description

The patient's physician reported that the patient passed.Cause of death is unknown.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

It was reported that the funeral home has the explanted devices available for return, however they have not been received to date.The cause of death was noted to be acute respiratory failure, pseudomonas pneumonia, status epilepticus, and hypertension as a contributing cause but not the resulting cause.The relationship to vns was not noted and remains unknown at this time.It should be noted that these are not official causes of death as there is no indication that the funeral home pulled this information off of the patient's death certificate.No other relevant information has been received to date.

Manufacturer Narrative

H3 other text: 02.

Event Description

The explanted generator and lead were received, however have not yet undergone product analysis.Additionally, the patient's death certificate was received which confirmed that the patient's cause of death was acute respiratory failure, pseudomonas pneumonia, and status epilepticus.No other relevant information has been received to date.

Event Description

Product analysis for both the lead and generator were approved.Analysis of the lead was performed and it was found through continuity checks, that no discontinuities were identified on the lead.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Note that since a significant portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Analysis of the generator was performed and it was found that there were no performance, or any other type of adverse conditions found with the pulse generator.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17321829
• MDR Text Key: 319005540
• Report Number: 1644487-2023-00907
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2024
• Device Model Number: 106
• Device Lot Number: 7228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/21/2023; 08/21/2023; 09/12/2023
• Supplement Dates FDA Received: 08/15/2023; 09/06/2023; 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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): Death
• Patient Age: 46 YR
• Patient Sex: Male