MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

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

Patient Problem Seizures (2063)

Event Date 01/14/2021

Event Type  malfunction  

Event Description

It was reported that at a follow up appointment, the patient had system diagnostics performed.It was noted that the patient was previously programmed to 0.25 ma output current for tolerability reasons, and therefore the system diagnostics being performed at 1 ma was higher stimulation than the patient could tolerate.Diagnostics were reported to be within normal limits.The patient went home following the appointment and reported pain in the neck and throat, as well as an increase in seizures.Upon reinterrogation, the patient's vns settings were found to be set to the parameters at which system diagnostics are run, indicating that the settings were higher than what the patient could tolerate.Per the physician, the settings were checked after the initial appointment and were verified to be at the intended settings, so the settings change was unexpected.The settings change was likely due to faulted diagnostics.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102R
• 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: 11287873
• MDR Text Key: 231123522
• Report Number: 1644487-2021-00193
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750023
• UDI-Public: 05425025750023
• 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
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/08/2017
• Device Model Number: 102R
• Device Lot Number: 4573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2015
• 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: 35 YR