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

Model Number 250

Device Problems Looping (1370); Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

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

Event Date 07/20/2016

Event Type  malfunction  

Event Description

It was reported by the physician that she had a frozen and unresponsive screen on her handheld programming system (hhd).The screen was noted prior to interrogating the patient.Prior to the call, the physician tried a battery-out restart and was unable to resolve the issue.The screen was cleaned, including under the bezel, and tried a hard reset.The physician had the device reboot and was unable to proceed past the alignment screen as it continually looped.A second hard reset was performed with the same outcome.The physician later confirmed that the device was stuck in the alignment loop where she continuously hit all of that ¿x¿ that appeared.The physician explained that this happened once a few weeks prior, but she was able to get it unfrozen.She also noted that she had the complaint hhd packed up and reach to be sent back.The physician also noted that she did not believe there was anything wrong with the patient¿s device and that the patient has come in since she received the new hhd and was checked.She noted she was able to increase the patient¿s settings and everything was working perfectly.

Event Description

The programming wand, programming computer (hhd), and associated programming software were received by the manufacturer.Product analysis (pa) for the returned wand was completed and no malfunctions were identified.No visual or mechanical anomalies were identified.Continuity testing of the serial data cable and the battery cable passed.The device met specification requirements and the programming wand performed according to functional specifications.Pa for the returned hhd was performed and analysis identified that the hhd was unable to advance past the welcome screen.The cause for the display anomaly was associated with resistance values being higher than expected in the touch screen circuitry.Once the display was replaced with a known good display, no further anomalies associated with the hhd performance were identified.Pa for the returned software was performed and no anomalies with the flashcard software or databases were identified.The flashcard and the software 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: 5885188
• MDR Text Key: 52414198
• Report Number: 1644487-2016-01863
• 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: 07/20/2016

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
• Device Lot Number: 1063824
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• 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
• Patient Age: 68 YR