MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problem Charging Problem (2892)

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

Event Date 08/04/2016

Event Type  malfunction  

Event Description

It was reported that the physician's handheld programmed was not holding a charge and required to be plugged into the wall.The physician was provided with a new programming tablet to replace the handheld programmer.The faulty handheld programmer has not been received to date.No additional relevant information has been received to date.

Event Description

The handheld programmer was received with the serial cable, ac power adapter and software flashcard.Product analysis is currently underway.

Event Description

Product analysis was completed on the handheld programmer.Visual analysis found that that the main battery of the handheld was swollen which caused the battery cover to bend.The bend in the battery cover prevented the battery cover from making sufficient contact with the battery latch switch on the main board which resulted in a false open battery latch condition.During analysis, a modified battery cover was installed and the handheld programmer was successfully powered on using the returned ac power supply.The main battery was then successfully recharged and used to perform interrogations and diagnostic tests.Analysis of the flashcard identified no anomalies with the software or databases.The flashcard and software performed according to functional specifications.The product analysis lab confirmed that the swollen battery was preventing sufficient contact between the battery cover and the battery latch switch on the main board.

• Brand Name: PROGRAMMING COMPUTER
• 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: 5911857
• MDR Text Key: 54064770
• Report Number: 1644487-2016-01947
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2016

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
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/13/2016; 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1