MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Loss of Power (1475); Failure to Power Up (1476); Device Stops Intermittently (1599); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A handheld computer and the flashcard were returned to the manufacturer due to exchange for a new motion tablet.During the physical inspection of the returned handheld, it was noticed that the main battery appealed to be swollen.No performance issue was reported from the facility.Review of manufacturing records confirmed all tests passed for the concerned handheld computer prior to distribution.Analysis of the returned handheld computer was completed and the "main battery swelling" allegation was verified.During the analysis it was identified that the handheld would not power on.The cause for the anomaly is associated with 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 of the returned flashcard was completed and no anomalies associated with flashcard software or databases were identified during the flashcard analysis.During the analysis it was identified that the flashcard contained a (b)(6) operating system file and folders.The presence of the file and folders is an indication that the flashcard was inserted into a device using the (b)(6) operating system.The file and folders had no impact on the vns software performance.The flashcard and software performed according to functional specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS; 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: 5805032
• MDR Text Key: 50731717
• Report Number: 1644487-2016-01624
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2016

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: MODEL 250
• Device Lot Number: 1063528
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1