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

Model Number 1000

Device Problems Failure to Deliver Energy (1211); Low impedance (2285); Physical Resistance/Sticking (4012)

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

Event Date 01/30/2024

Event Type  malfunction  

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 patient was seen to have low impedance and was referred for surgery.The patient underwent surgery and only their generator was replaced.The lead impedance was within normal limits after the generator was replaced.Although the impedance resolved with only the generator being changed, there is not enough evidence at this time to rule out a lead issue.No known surgical intervention has occurred to date with the lead.No other relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.An interrogation and system diagnostic tests were performed.The device output signal was monitored for more than 24-hrs and did not perform as expected.A magnet swipe was done to activate the magnet current to capture the duts ramps, so all duts ramps could be captured on the first page.However, the reed switch appears to have stuck closed as the output signal did return after the magnet was applied.Tapped on the dut for the first hour, but the output signal did not return.It appears the reed switch released on its own as the output signal returned approximately 5 hours after the 24-hour monitoring period had begun.A comprehensive automated electrical evaluation (shows an ifi=no condition) was performed.Other than the reed switch stuck closed condition during the output signal monitoring period, the dut performed according to functional specifications.Device history records for the generator was performed.The generator passed final functional and quality specifications prior to release for distribution.

• 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: 18766432
• MDR Text Key: 336081628
• Report Number: 1644487-2024-00182
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 04/23/2024

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: 1000
• Device Lot Number: 7651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2023
• 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: 15 YR
• Patient Sex: Male