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

Model Number MODEL 250

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2014

Event Type  malfunction  

Event Description

It was reported that the physician's handheld has a swollen battery.It was reported that the physician experienced issues with the display and removed the battery to reset, but that when the battery was removed, it was noticed to be swollen.A new programming tablet was provided to the physician and the handheld and flashcard were returned to manufacturer for analysis.Analysis is underway, but has not been completed to date.

Event Description

Additional information was received stating that the nurse¿s handheld device was stored in a drawer.It was reported that no mishandling had occurred.

Event Description

An analysis of the handheld verified that the main battery was swollen, but that the handheld performance was not affected.No performance anomalies associated with the main battery were identified during the analysis.The handheld performed according to functional specifications.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a 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: 3622544
• MDR Text Key: 4132616
• Report Number: 1644487-2014-00383
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• 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: 1075226
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1