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

Model Number MODEL 250

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

Suspect device software version: version 11.0.5.

Event Description

Information was received indicating that there was an issue with a physician's tablet not holding a charge.Troubleshooting was attempted and the charger was exchanged with a known good charger, adequate time for charging was provided, and multiple outlets were attempted.However when the physician's tablet was unplugged it would power off.No patient therapy was affected since the tablet was functional when plugged in.The tablet was received and is undergoing product analysis.No additional relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The physician's tablet was received with a depleted battery.After being allowed to charge for 3 hours the battery still showed that it was depleted.The tablet case was opened where it was identified that a cable that connects the main battery to the tablet motherboard was loose.The cable was reseated and the tablet was then charged.Once the cable was reseated all functionality was restored to the tablet.

• 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: 6228483
• MDR Text Key: 64037169
• Report Number: 1644487-2016-02923
• 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
• Report Date: 01/27/2017

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: MODEL 250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1