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

Model Number	102R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seizures (2063)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11287873
• Report Number: 1644487-2021-00193
• Device Sequence Number: 19794871
• Product Code: LYJ
• UDI-Device Identifier: 05425025750023
• UDI-Public: 05425025750023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/08/2017
• Device Model Number: 102R
• Device Lot Number: 4573
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR