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

Model Number MODEL 250

Device Problems Intermittent Continuity (1121); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

A user reported that when using his finger on the touch screen to navigate on his tablet motion programmer, the screen was not consistently responsive.At times the user was unable to navigate to the desired screen due to the reported screen responsiveness issue.The suspect tablet motion programmer has been returned to the manufacturer and is currently undergoing product analysis.

Event Description

No functional anomalies were noted with the tablet programmer.The cap of the digitizer pen returned with the tablet programmer was not completely secured on the pen base due to a bent pen case.The pen case appeared to be physically damaged.Once the case was bent back into its original shape the cap was able to be secured onto the base with no anomalies.

Manufacturer Narrative

Describe event or problem, corrected data: this information was inadvertently not included in manufacturer supplemental report #1.

Event Description

Despite mechanical damage to its barrel, the digitizer pen operated as expected on the tablet screen.The tablet screen also functioned as expected in response to finger commands.

• 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: 5082699
• MDR Text Key: 26255169
• Report Number: 1644487-2015-05790
• 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: Followup
• Report Date: 08/19/2015

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
• Other Device ID Number: VERSION 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2013
• 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