MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Low impedance (2285); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 01/30/2019

Event Type  malfunction  

Event Description

It was reported to a company representative that a patient was "having some trouble" and vns is "going out".The physician saw the patient and stated that the vns was "failing".Follow up with the physician clarified that the "trouble" was the patient not feeling stimulation and experiencing an increase in seizures.The device was suspected to be "failing" due to the patient's breakthrough increased seizures.The physician did not have an assessment of the cause of the reported events.It was further indicated that no intervention was planned or taken for the events to date.Diagnostics were reported to be showing low output status and low impedance.No additional, relevant information was received to date.

Event Description

Information was received that the patient is being referred for replacement due to battery nearing end of service.Clinic notes for the patient were also received indicating the patient had an increase in seizures and the patient's mother wanted vns turned back on as she had previously requested the output current be set to 0ma.After discussion with the mother, the device was turned back on to 1ma.During follow-up with the physician¿s office, it was indicated that the device was turned off per the mother¿s request as she did not feel the patient was benefitting from vns and device was nearing end of service.The patient then had an increase in seizures while the device was off and not delivering therapy, therefore the mother wanted the device back on as she saw the vns was helping the patient¿s seizures.The physician indicated that there was no assessment available as to whether or not the patient was benefitting from vns since the patient was first seen by him when the device was turned off and nearing end of service.He indicated that the mother did not want to proceed with a replacement at the time but will now be having a replacement due to battery nearing end of service.It was inquired about the reported low impedance and low output status by his office and indicated that was reported by mistake as there was no low impedance or known impedance issues.The physician indicated that when the device was turned back on, there were no problems with impedance either although the exact impedance value was not available.

Event Description

Implant card was received indicating the patient had a battery replacement due to battery depletion.The generator was received into product analysis and analysis is currently underway.

Manufacturer Narrative

Suspect medical device ¿ correction ¿ inadvertently did not update the suspect product to be the generator in supplemental #01 submitted as it was indicated by the physician there was no impedance issue therefore the suspect product for the increase in seizures is the generator.

Event Description

Product analysis (pa) was completed on the returned generator.Although the reported allegations of ¿increased seizures¿, and ¿stimulation not perceived¿ cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified.This was successfully verified in the pa lab.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the pulse generator), demonstrate the appropriate magnet output for the programmed settings.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.639 volts as measured during completion of the final electrical test, shows an ifi=yes condition.The data in the diagaccumconsumed memory locations revealed that 95.440% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 103
• 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: 8476666
• MDR Text Key: 140778099
• Report Number: 1644487-2019-00646
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2010
• Device Model Number: 103
• Device Lot Number: 2370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2009
• 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: 17 YR