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

Model Number 1000

Device Problems Failure to Deliver Energy (1211); Physical Resistance/Sticking (4012)

Patient Problem Convulsion, Clonic (2222)

Event Date 12/23/2021

Event Type  malfunction  

Manufacturer Narrative

This report was due on november 29, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 20, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.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 patients device could not run diagnostics, that error code 254 was seen.A generator reset was performed in which error code 4 was seen as well as low impedance.Additional information was received noting that the patient has experienced an increase in seizures.Internal generator data was received and reviewed.Upon analysis it was found that the reed switch was stuck close.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B2.Outcomes attributed to adverse event, b5.Describe event or problem, d6b.If explanted, give date (mo/day/yr), f10.Adverse event problem ¿ health effect ¿ impact code, h6.Adverse event problem codes - type of investigation, corrected data; initial mdr inadvertently omitted information known prior to submission.

Event Description

Information was received that patient had a battery replacement.The explanted device has not been received to date.No other relevant information has been received to date.

• 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: 18273603
• MDR Text Key: 329826842
• Report Number: 1644487-2023-01738
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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: 04/22/2021
• Device Model Number: 1000
• Device Lot Number: 204895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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
• Patient Age: 34 YR
• Patient Sex: Female