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

Model Number MODEL 250

Device Problems Malposition of Device (2616); Battery Problem (2885); Reset Problem (3019)

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

Event Date 01/21/2016

Event Type  malfunction  

Event Description

It was reported that the battery latch was not locking properly on the physician's handheld computer, leading to computer resets.The product has not been returned for analysis to date.No additional pertinent information has been received to date.

Event Description

Additional information was received that the physician's office was still able to use the handheld device despite the impact of the allegedly faulty battery latch on device performance.The device has still not been returned to the manufacturer to date.No additional pertinent information has been received to date.

Event Description

The physician's handheld computer was returned to the manufacturer and is undergoing product analysis.No additional pertinent information has been received to date.

Event Description

Product analysis was completed on the returned handheld computer and flashcard on 05/26/2016.Attempts were made to power on the handheld using the returned power supply, but these were unsuccessful.Visual inspection of the handheld identified that the battery cover was bent due to a swollen main battery.As a result, the battery cover was unable to make good contact with the battery latch switch that was on the main board.This resulted in the handheld receiving a false open battery latch condition.After installation of a modified main battery cover, the handheld device was powered on using the returned ac power supply with no anomalies.No further anomalies were identified.No anomalies associated with the battery latch were identified.An analysis was performed on the returned 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: 5437201
• MDR Text Key: 38864558
• Report Number: 1644487-2016-00280
• 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,Followup,Followup
• Report Date: 01/21/2016

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: 1073772
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/17/2016; 05/19/2016; 06/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2010
• 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