MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Complaint, Ill-Defined (2331); Abdominal Cramps (2543)

Event Date 09/22/2015

Event Type  malfunction  

Event Description

It was reported that a vns patient's device had an abnormal change in programming parameters / settings during 19 months after implant.It is not clear if the parameters were changed voluntary.It was reported that the patient experienced several adverse events during that period, that were said to be possibly or probably related to stimulation (abdominal cramps, larynx spasms, coughing and voice alteration with social impact).It was reported that these events may have led to the change in programming settings.The site indicates an off time of 180 minutes on the last recorder parameters with 0ma, on (b)(6) 2015.This was double-checked and confirmed by the physician.The normal mode stimulation parameters were as follows: output current, 0ma / frequency - 20hz / pulse width - 130usec / on time, sec / off time, 80min.No additional relevant information was received to date.

Event Description

Further information was received indicating that the reported 0ma (device disabled on (b)(6) 2015) was due to the adverse event: voice alteration.That event started on (b)(6) 2014 and the severity was mild.It was reported that the event was probably related to vns implant and probably related to vns stimulation.It was reported that the event was not a serious adverse event and it did not cause the subject to discontinue from the study.No further information was provided to date.

Event Description

Addition information was received indicating that the physician confirmed she programmed the generator to 0ma of output current and 180 min off times, following several patients adverse events already reported.The physician indicated that this was done intentionnally.It was reported that no device issue occurred.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5321978
• MDR Text Key: 34937071
• Report Number: 1644487-2015-06834
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR