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

Model Number 1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Choking (2464); Cough (4457)

Event Date 12/09/2022

Event Type  Injury  

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 patient experienced an increase perception of stimulation accompanied by a tickle in his throat that progressed to coughing, choking, and difficulty breathing as the perception of stimulation increased throughout the day.The patient reports feeling the device continuously stimulating.The patient got on a facetime call with the managing physician who instructed the patient to hold the magnet over his chest to disable the stimulation.This reportedly did not work and the patient called ems who arrived and taped the magnet over his chest which disabled stimulation.The patient was taken to the hospital where the managing physician arrived to disable the device.It was noted that the patient is taking anticonvulsant medications.Tablet data was received and the decoder for the patient's device was reviewed.Therapy was delivered as programmed.The patient was seen to be set to the lowest autostim threshold of 20%.A review of the hourly tab indicated that the patient received several autostims ranging from 9 per hour to 135 per hour.The patient's foreground heartrate was seen at an average of 120bpm no anomalies from the decoder were seen.Further information was received from the managing physician who confirmed the events took place as reported and that disabling the device was to preclude a potential serious injury.The low autostim threshold was discussed and concluded that the patient was receiving stimulation from an elevated heart rate not associated with any seizure event, that the physician had the autostim threshold set too low for the patient.The physician plans to resume therapy for the paitient with a more appropriate autostim threshold.Device history records were reviewed.The device passed all functional and quality testing prior to distribution.No other relevant information has been received to date.

Event Description

It was later reported that therapy has been re-enabled.

• 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: 16103528
• MDR Text Key: 306716798
• Report Number: 1644487-2023-00009
• 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: 03/29/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2020
• Device Model Number: 1000
• Device Lot Number: 205042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male