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

Model Number MODEL 250

Device Problem Failure to Charge (1085)

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

Event Date 01/04/2016

Event Type  malfunction  

Event Description

The psychiatrist reported his handheld programming computer would no longer hold a charge.It was noted the device would light up when plugged into the wall, but it would immediately shut off after being unplugged from the wall.No additional relevant information has been received to date.

Event Description

The physician stated that he did receive the box which included the replacement product; however, he had not opened it.Additionally, a returned product kit was sent to the physician so that he could returned the complaint handheld programming device to the manufacturer for analysis.Attempts were made to have the product returned; however, they have been unsuccessful to date.

Event Description

The handheld programming computer was received with it's associated software.Device analysis is expected but has not been completed to date.

Event Description

Product analysis on the returned handheld programming computer was completed.Analysis showed the allegation of the handheld computer not holding a charge was not verified.No anomalies associated with the handheld computer's performance were noted during testing using an ac adapter or the main battery with a full charge.The handheld computer performed according to functional specifications.Product analysis on the returned software was completed.Analysis was performed on the returned flashcard and no anomalies associated with the flashcard software or databases were identified.The flashcard and software performed according to functional specifications.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 5401156
• MDR Text Key: 37734817
• Report Number: 1644487-2016-00185
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 863936
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 02/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/21/2016; 04/14/2016; 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2008
• 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