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

Model Number MODEL 250

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during generator replacement surgery the company representative's tablet would not respond to touch and was frozen on the interrogation screen.The tablet had functioned properly the day before and the tablet was charged over night.The tablet was completely powered off and back on however the issue persisted.The surgeon's tablet was then used and the patient was successfully interrogated during surgery.The company representative was provided with a new tablet.The manufacturing records of the tablet were reviewed and it indicated that the tablet passed qc inspection.The frozen tablet has not been received to date.No additional relevant information has been received to date.

Event Description

The tablet was received and is currently pending product analysis.

Event Description

Product analysis was completed on the tablet.Upon receipt it was noted that the main battery had been depleted so the tablet was connected to a known good power source.The tablet was then able to be successfully powered on and booted to the vns welcome screen.However the pa lab was unable to perform interrogations and noted that the touchscreen was unresponsive.The tablet case was opened and visual analysis did not find any anomalies on the main board or cables.The tablet display was then replaced with a known good display and the lab was able to successfully perform interrogations or diagnostic tests.The main battery was then fully recharged and the tablet performed to functional specifications.The pa lab confirmed that the tablet screen was unresponsive and noted that it was associated with a defective touchscreen display.

• 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: 5766188
• MDR Text Key: 49398446
• Report Number: 1644487-2016-01490
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 11.0.4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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