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

Model Number MODEL 250

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Misassembled (1398); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

An analysis was performed on the returned handheld, and the reported allegation was verified.Visual analysis verified that the handheld was returned without a battery cover.As a result, the handheld would not power on.Additionally, it was also identified that the main battery was inserted backwards.As a result, the handheld was unable to be powered using battery power.Once the main battery was inserted correctly, and a known battery cover was installed, the handheld performed according to functional specifications.The flashcard and software performed according to functional specifications.

Event Description

It was reported that the physician¿s programming handheld was freezing, and the back battery door was missing.A replacement tablet was provided.The suspect handheld was received by the manufacturer for analysis.The handheld battery was received with the battery backwards, in addition to the battery cover missing.However, the analysis has not been completed to date.

• 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: 4519676
• MDR Text Key: 5357731
• Report Number: 1644487-2015-03857
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

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: 857134
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1