MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Under-Sensing (1661)

Patient Problem Seizures (2063)

Event Date 03/01/2019

Event Type  malfunction  

Event Description

It was reported that the patient was admitted to the hospital for seizures.It was stated that the patient's new vns generator was programmed to the patient's previous vns' settings and that there were no autostim detections.The physician increased the autostim sensitivity parameter.It was unknown if the physician was attributing the increase to the vns generator's lack of autostim detections.The patient's previous vns generator had issues with detecting tachycardia events for autostim as well.The previous generator was received by the manufacturer and is pending product analysis.No additional relevant information has been received to date.

Event Description

The patient's previous generator product analysis was completed.Proper functionality of the generator in its ability to provide programmed output currents was verified in the product analysis, or pa, lab.The allegation of undersensing/no r-waves detected was not duplicated in the pa lab.The generator was placed in a simulated body temperature environment and monitored for more than 24 hours.No variation in the output signal was observed and the device provided the expected level of output current.Diagnostics were as expected.The generator performed according to functional specifications.There were no performance or other adverse conditions found with the generator.Follow up with the company representative revealed that the increase in seizures was not above the pre-vns baseline.The surgeon did not perform a pre-surgical evaluation prior to the implantation of the autostim capable generators.It was stated that at the recent surgery, they were able to match the physician's heart rate monitor exactly during heart rate verification.

Event Description

Follow up with the company representative revealed that the patient was doing better.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8471156
• MDR Text Key: 140543696
• Report Number: 1644487-2019-00629
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2020
• Device Model Number: 106
• Device Lot Number: 5972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• 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): Hospitalization
• Patient Age: 34 YR