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

Model Number MODEL 250

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Power Problem (3010)

Patient Problem No Information (3190)

Event Date 07/15/2016

Event Type  malfunction  

Event Description

It was reported by a company representative that a physician's handheld was unable to stay powered on for more than a few seconds whether it was plugged in or not.The handheld programmer is showing a message that the battery latch is open, even though it is closed.It was state the battery cover seems to be bulging out slightly, but it still gives the same warning message when it is held down.The representative stated the battery did not appear to be swelling.Additional relevant information has not been received to-date.The handheld has not been received by the manufacturer to-date.

Event Description

The handheld programmer was received with the serial cable, flashcard and power supply adapter on (b)(6) 2016.Analysis is underway for the returned products but has not been completed to-date.

Event Description

Analysis was completed for the handheld and no anomalies associated with the battery latch were identified during the analysis.During the analysis, it was identified that the handheld would not power on due to a swollen main battery.The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on.This condition can also cause the handheld to power off intermittently.No further anomalies were identified.Analysis was completed for the flashcard.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and 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: 5869949
• MDR Text Key: 52336176
• Report Number: 1644487-2016-01804
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• 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: 1073772
• Other Device ID Number: VERISON 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2011
• 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