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

Model Number 1000

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Defective Component (2292); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Convulsion, Clonic (2222)

Event Date 05/01/2023

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 in april the patient's device was checked and their battery was ok and the impedance was within normal limits.X-rays taken at that time were normal as well.Then in may the patient reported an increase in seizures, above pre vns levels.When the device was attempted to be checked in september the device could not be interrogated despite troubleshooting steps of wand battery re-insertion, wand and tablet restart, wired connection, and generator reset, but nothing worked.They kept getting "generator not found".The doctor used their tablet and wand as well as the rep's tablet and wand without success.They also interrogated the demo generator with no issues.Patient has been referred to surgeon where the device was replaced due to battery depletion and returned for product analysis.The device is undergoing testing.No other relevant information has been received to date.

Event Description

Additional information was received from the physician indicating, the cause of the increased seizures is due to lack of vns stimulation as the physician reported the device stopped stimulating.There are no other factors that they would attribute to the increased seizures and the battery replacement was noted as the intervention for the seizures.They also note that the failure to program is attributed to device malfunction as the implant depth and device location were verified and not an issue.Product analysis completed testing for the generator (dut) and confirmed the device did indeed fail.The generator would not interrogate.Therefore, a system diagnostic test, a wand communication diagnostic, and final electrical test could not be performed.X-rays taken of the device, while still in the case, revealed no visual anomalies.The generator case was cut, but not removed.Communication was checked, but still would not interrogate.With the battery still attached to the pcba, the battery measured 1.783 volts (series resistor measured 0.114mv (114ua)), an end of service=yes condition (eos =/> 2.19v).The therapy application was not running.The battery was removed from the generator.The generator pcba was summited to a postburn test and did not perform according to functional specifications.A number of test parameters related to ¿supply current¿ and ¿output current¿ were found to be out of specification.The standby current measured high at 6ua (typically 3-4ua).The dut pcba was interrogated.The dut pcba was programmed to 1ma, 20hz, 250us, 14sec on, 0.5min off and 2ma, 20hz, 250us,14sec on, 0.5min off (4k ohm load) to check functionality.The signals observed on the bench oscilloscope suggest a rapid discharge.The pulse generator would not communicate when received and tested in the livanova product analysis lab.It was also determined that the battery voltage indicated end of service=yes and that the therapy application was not running.Based on the function analysis the capacitor from the dut pcba appears to be the cause for the increased current consumption of the pulse generator and may have been the contributing factor for the reported allegations.The cause for the capacitors increase in leakage current was not determined.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: 17997058
• MDR Text Key: 326410787
• Report Number: 1644487-2023-01529
• 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: 11/17/2023

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: 04/11/2024
• Device Model Number: 1000
• Device Lot Number: 7212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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 Age: 21 YR
• Patient Sex: Female