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 Problem Arrhythmia (1721)

Event Date 06/10/2019

Event Type  Injury  

Event Description

It was reported that the patient was experiencing tachycardia and the physician was not sure if it was related to vns stimulation.The vns was disabled in order to assess the event.Follow up with the physician's office revealed that the patient has a history of cardiac issues.However, the relation between the vns and the reported tachycardia is still unknown to date as the patient had no events since the vns was programmed off.It was stated that the output current was only around 1.00 ma and the diagnostics were within normal limits.The vns was programmed back on after the disablement period.No additional relevant information has been received to date.

Event Description

It was reported that the patient was experiencing bradycardia after the vns was programmed back on.Tablet data was received and review revealed that the device was programmed off with the exception of the magnet mode initially and then, two weeks later, the autostim mode was programmed on to low settings.Review of the data revealed that all results of diagnostic testing were within normal limits.The last autostim mode diagnostics was a few months prior and was within normal limits.

Event Description

The patients device is only programmed on for autostim, and is receiving about 50 autostims per day.The autostim sensitivity is 5 and threshold is at 70%.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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8763005
• MDR Text Key: 150107319
• Report Number: 1644487-2019-01287
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2020
• Device Model Number: 1000
• Device Lot Number: 204751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• 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): Other
• Patient Age: 73 YR