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

Model Number	102R
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient has an m102r and it reportedly reset to 60 min off.Programming history was received and reviewed.History showed that the patient was interrogated at an output current of 1.75ma on (b)(6) 2019 with an off time of 60 minutes and was previously at an output of 1.5ma on (b)(6) 2019 and an off time of 0.8 minutes.There is no programming event to show how the patient's setting were changed and it is unclear if the patient saw a different physician during the time between the february appointment and april appointment where settings may have been adjusted.Other than the noted events, there are no other anomalies within the programming history.No additional or 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: 8554637
• Report Number: 1644487-2019-00793
• Device Sequence Number: 2259972
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: 07/07/2018
• Device Model Number: 102R
• Device Lot Number: 203875
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR