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

Model Number MODEL 250

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

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

Event Date 01/01/2015

Event Type  malfunction  

Event Description

It was reported that the handheld device would only work while it was charging.Once the handheld was disconnected to the power adaptor, the screen went blank.The handheld device has not been returned to date.

Event Description

The handheld computer and the software flashcard were retuned to the manufacturer on 03/16/2015.Analysis of the handheld computer found no anomaly associated with the performance of the handheld¿s display.The handheld was returned without a battery cover.As a result, the handheld would not power ¿on¿.A known good battery cover was used to complete testing.One of the leaf springs associated with the main battery terminal on the main pcb was bent which rendered the main battery unable to establish electrical contact with the handheld, which did not permit the battery recharge using the ac power.Also the handheld was unable to be powered using the main battery.Once the leaf spring was bent back into place, the handheld performed according to specifications.Analysis of the flashcard identified no anomalies associated with flashcard software.The flashcard and software performed according to functional specifications.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4519346
• MDR Text Key: 5492919
• Report Number: 1644487-2015-03851
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• 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: 1063834
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1