MAUDE Adverse Event Report: CYBERONICS, INC. MODEL 250; PROGRAMMING SOFTWARE

Model Number 102

Device Problems Loss of Power (1475); Device Inoperable (1663); Low Battery (2584); Communication or Transmission Problem (2896)

Patient Problems Therapeutic Response, Decreased (2271); Depression (2361)

Event Date 10/25/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

Clinic notes were received indicating that a patient's generator was at end-of-service and the patient's depression symptoms were getting gradually worse since the summer of 2015.The patient reported that her depression was not as bad as in 2007 prior to vns implant.The physician stated that the device "reduced its firing and then in (b)(6) 2015, it would no longer function." clinic notes from (b)(6) 2015 indicate that the device was at near end of service and notes from (b)(6) 2015 indicate that the device was at end-of-service.In both visits the physician reported that the vns has turned itself off and would not allow to adjust stimulation above 0 ma.The device was able to be interrogated and run normal mode diagnostics on (b)(6) 2015.The physician reported he could not turn the system back on.The patient was referred for battery replacement.To-date, due to the reported low battery condition it is suspected that the generator had sufficient power to interrogate the device, but insufficient power to complete systems diagnostics or program the device which could unintentionally program the device to 0ma after the failed diagnostic test.No additional relevant information has been received to-date.No known surgery has occurred to-date.

Event Description

Follow-up from the physician was received.The physician responded that systems diagnostics were performed on (b)(6) 2015 and (b)(6) 2016 with results within normal limits.The physician indicated that he was unable to change the output from 0 to 0.25, but based upon the settings provided for the date of (b)(6) 2016, the physician was successful in turning the device output current to 0.25ma.The battery status was provided as near end of service.

Manufacturer Narrative

(b)(4).

Event Description

Based on the available information, the cause of the generator not being able to be programmed to anything other than 0ma was not due to a low battery causing a communication issue that changed the settings.The reason for the generator settings spontaneously changing to 0ma was not identified with the information available.Information was later received indicating that no further programming occurred since (b)(6) 2016, and the battery was completely depleted as of 10/27/2016.A battery life calculation estimated 0yrs until eri=yes.No known surgery has occurred to date.

Manufacturer Narrative

Suspect medical device, corrected data: the previous reports inadvertently listed the incorrect suspect device.

Event Description

After further review of the available programming history, the most likely cause of the change in settings was due to a communication fault during the office visit caused by the low battery status of the generator.The change in settings happened only on one occasion, and the settings had not changed from one office visit to another.

• Brand Name: MODEL 250
• 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: 5393027
• MDR Text Key: 37428589
• Report Number: 1644487-2016-00150
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2008
• Device Model Number: 102
• Device Lot Number: 015709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 01/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2016; 11/22/2016; 06/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR