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

Model Number MODEL 250

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the vns physician handheld device displayed an "unrecognized card" error message.The flashcard was re-inserted and a hard reset was performed.After the "clear all data in memory" prompt was completed, the error message appeared again.The handheld device has not been returned to date.

Event Description

The handheld device and software flashcard were returned to the manufacturer for analysis which was completed on (b)(6) 2016 and identified that the vns software would not load when the returned flashcard was inserted.The cause for the anomaly was associated with a bent pin found in both the handheld flashcard slot and the software flashcard socket.Once the pins were straightened, no further anomalies the handheld and software flashcard were noted.Based on the information available, the root cause of the bent pin is most likely due to the user inserting the flashcard incorrectly.The manufacturer report capturing the software flashcard as the suspect device was reported in mfr.Report # 1644487-2016-00282.

• 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: 5354854
• MDR Text Key: 35792287
• Report Number: 1644487-2016-00062
• 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: Medical Assistant
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Device Lot Number: 1075855
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2010
• 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