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

Model Number MODEL 250

Device Problems Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2014

Event Type  malfunction  

Event Description

Analysis of the returned handheld device was completed.The cause for the reported allegation is associated with a defective main battery.During testing, it was also identified that the main battery was unable to power the handheld, giving further indication that it is defective.Further analysis identified that the handheld would not power on.The cause for the anomaly is associated with the swollen main battery.The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing it from powering on.No further anomalies were identified.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

Event Description

It was reported that the handheld device¿s battery was damaged.The handheld device would only work when plugged into its power adaptor; however, the handheld device would frequently restart and display the following warning message: ¿the battery latch was opened.The system was put into sleep mode.¿ the battery latch was reported to be fine, but the battery was puffed up and was pushing up against the battery latch.The handheld device was returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

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

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution.

• 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: 3856628
• MDR Text Key: 4555427
• Report Number: 1644487-2014-01442
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• 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: 1063524
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1