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

Model Number 1000

Device Problem Mechanical Problem (1384)

Patient Problem Seizures (2063)

Event Date 11/19/2020

Event Type  malfunction  

Event Description

It was reported that low output current message was seen on a m1000 generator.Two weeks prior, the patient lost perception of stimulation and his seizures returned (implying increased seizures).The patient couldn't even feel her magnet swipes when her magnet output current was programmed to much higher than typical.The doctor reported that they were having major issues communicating with the generator.Impedance values and battery status was okay.Follow-up found that error code 254 was observed while interrogating the device.This error code is typically related to the generator's reed-switch being stuck closed.When the reed switch is stuck closed, the patient will not receive stimulation from the generator.Data review of the internal generator data confirmed that the vns reed switch was closed since mid-november and would not be providing stimulation.The manufacturer's device history records of the m1000 generator were reviewed.The generator passed final functional and quality specifications prior to release.No known surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that they tried swiping the magnet over the generator site and tried resetting the generator and it didn't resolve the problem.No known surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The patient's generator was replaced due to the reed switch malfunction.The suspect product has not been received for analysis to date.No further relevant information has been received to date.

Event Description

The suspect generator was received for analysis but analysis has not been completed to date.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.Reed switch failure was verified.As received the generator was able to be communicated with and diagnostics were ran and found to be within normal limits.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.The generator showed signs of variation in the output and magnet signals after the magnet was applied to the pulse generator.The magnet was applied to the pulse generator for approximately 25-minutes and then removed from the pulse generator.After the magnet was removed from the pulse generator the outputs (output or magnet) did not resume, indicating a closed reed switch.Prior to the magnet being applied to the pulse generator, the output signals demonstrated the expected level of output and magnet currents.The generator performed according to functional specifications except for the magnet detection specification.The reed switch was removed from the generator and underwent a functional test and performed according to specifications.However , after a magnet was applied to the reed switch, the reed switch failed functional specifications and the reed switch was determined stuck closed.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
• MDR Report Key: 11092714
• MDR Text Key: 224397798
• Report Number: 1644487-2020-01749
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2021
• Device Model Number: 1000
• Device Lot Number: 204921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Event Location: Other
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1