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

Model Number 250

Device Problems Failure to Charge (1085); No Device Output (1435); Loss of Power (1475); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician's tablet was not able to stay on or stay charged.It was noted the tablet lights would blink when plugged in and that the wand was working correctly.Troubleshooting was later performed and the issue was clarified noting power button light would blink orange and caused the screen to freeze, delaying the programming process.A hard re-set was performed which seemed to resolve the issue.As the issue would only present itself every few days, it was unknown if the hard re-set had adequately resolved the issue.A new power cable was requested, as a precaution, and the physician was informed to notify the manufacturer if the problem persisted.It was later clarified that no troubleshooting had been performed on the power cable to see if it was causing the issue, and no troubleshooting was performed on the power outlets to verify whether or not they were working correctly.It was noted the physician had an issue with the tablet the day after the hard re-set, but has not had an issue with the tablet since the new power cable was distributed to him.It was also noted that on the day of troubleshooting and the hard re-set, the reported issue did not present itself, but the issue did occur the day before and the day after the troubleshooting.On the day of the troubleshooting the tablet battery was checked and showed about 80%; however, it is unknown what the tablet battery was during the time of the reported issues.It was noted that while not in use, the tablet is stored in a cabinet and is not charging while in the cabinet.Additionally, it was noted that on the date of an appointment the tablet will be taken out of the cabinet the morning of the appointment and plugged in to charge, if the facility remembers to do so.No patients were affected by the tablet not holding a charge or the tablet screen freezing issue as there was another vns programming system available for use within the facility.Attempts for additional relevant information have been unsuccessful to date.

Event Description

The power cable associated with the programming system was received by the manufacturer on 11/09/2016.Analysis is expected, but has not been completed to date.

Event Description

Product analysis for the returned ac adapter cable was completed.Analysis was unable to verify the allegation of the vns programming system not holding a charge as no anomalies associated with the ac adapter performance were noted during testing using a known good tablet.The ac adapter performed according to functional specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 6070250
• MDR Text Key: 59040976
• Report Number: 1644487-2016-02534
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup,Followup
• Report Date: 12/19/2016

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: Health Professional
• Device Model Number: 250
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Clinic - Walk In; Other
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/05/2016; 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• 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