MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Bent (1059); Device Inoperable (1663); Material Deformation (2976)

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

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the handheld programmer and wand were being returned due to the facility receiving a new tablet and wand.It was noted that the handheld programmer was not holding it's charge long enough to complete a memory download.The handheld had been adequately charged to gain a full battery when the issues with the battery life were observed.The handheld programmer and wand were received.Product analysis was completed on the wand and the flashcard containing the software.Analysis found that both performed according to functional specifications.Product analysis on the handheld found that the battery was swollen which caused the battery cover to bend.As a result the battery cover could not make sufficient contact with the battery latch switch.This caused the handheld device to be inoperable.The cause of the swollen battery is not clear however it appears that it may be related to the usage of the battery.The handheld device was powered on using the ac power supply and the handheld device was successfully charged.The handheld then successfully performed interrogations and system diagnostic tests.

• Brand Name: PROGRAMMING COMPUTER
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5777393
• MDR Text Key: 49763207
• Report Number: 1644487-2016-01531
• 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: Other
• Type of Report: Initial
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• 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: 06/16/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2010
• 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