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

Model Number 1000

Device Problem Mechanical Problem (1384)

Patient Problems Emotional Changes (1831); Pain (1994); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/12/2018

Event Type  malfunction  

Event Description

It was reported that the physician was unable to take the patient out of guided/scheduled programming mode.The physician received a programming error message repeatedly.Two different programmers were used but this did not resolve the issue.Later it was indicated that an error code associated with reed switch failure was observed.The internal data of the generator was reviewed.Battery voltages and impedances from up to implant date were within normal limits and there was no evidence of reboot.The run state for all programming operations on (b)(6) 2019, the date when the physician was unable to take the patient out of guided programming, was "stimulation inhibited".It was found that the generator had last checked voltage and impedance on (b)(6) 2018, which indicates that the generator had been disabled/inhibited since that time.There were a large number of magnet swipes the following day.This behavior is consistent with what occurs when the generator's reed switch is stuck closed.At the patient's follow-up, the patient's generator was reset.Diagnostics indicated low impedance, which evidences that the reed switch was closed.The patient's family reported that they had placed the patient's magnet on the generator for a few days on (b)(6) 2018.The patient's parents also said that the magnet may have been less effective at aborting seizures than it was at the beginning.Session reports from this follow-up appointment indicate that autostimulation and normal mode stimulation had occurred since the last visit, which indicates that the reed switch was unstuck for some amount of time.The manufacturer's device history records were reviewed.The generator passed final quality and functional specifications prior to release no further relevant information has been received to date.

Event Description

It was determined through data review that the reed switch became unstuck for six days and then become stuck again.No further relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

Product analysis was completed on the suspect generator.The generator was subjected to a final electrical test.The generator failed magnet detection specifications (reed switch closed in a low gauss strength magnetic field where the switch contacts should remain open).All other parameters were within specification.Electrical test of the removed reed switch verified that the component did not meet specification, the switch closure occurred in a magnetic field that is below the minimum specification.The reed switch closed in a 1.05mt magnetic field while the specification requires a minimum of 1.2mt.Other than the noted condition there were no other adverse functional, mechanical, or visual issues identified with the returned generator per a review of the data dump time stamps, it was determined that the reeds switch had closed on (b)(4) 2019 which indicates that it had opened at some point in time prior since the last time it closed.Per device history records, the reed switch did not respond to magnet field below specification during manufacturing electrical tests.No further relevant information has been received to date.

Event Description

The patient's generator was replaced due to the reed switch issue.The generator was received for analysis but product analysis had not been completed on the product to date.

Event Description

The physician reported that he had actually had been able to interrogate the device and it seemed to be working fine and it was already ¿on¿ at the intended output current; however, the reed switch would not be expected to change the output current stimulation, just inhibit stimulation.Then the physician reported that when he tried to enable autostimulation he ran into issues.With regards to the reed switch failure, the generator is unable to sense while the reed switch is closed and so autostimulation cannot be enabled with reed switch failure.No further relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

The patient's father reported that as a result of the reed switch failure previously reported the patient suffered permanent physical and emotional injuries, pain, suffering and loss of enjoyment of life.He also reported that the patient suffered permanent and continuous injuries, pain and suffering, disability and impairment.No further 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8384053
• MDR Text Key: 137668299
• Report Number: 1644487-2019-00397
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/17/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2019
• Device Model Number: 1000
• Device Lot Number: 204336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 03/04/2019; 09/25/2019; 10/24/2019; 12/18/2019; 06/24/2020
• Supplement Dates FDA Received: 03/28/2019; 10/18/2019; 11/19/2019; 01/06/2020; 07/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2018
• 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): Disability
• Patient Age: 6 YR