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

Model Number MODEL 250

Device Problems Failure to Power Up (1476); Charging Problem (2892)

Patient Problem No Information (3190)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

A physician reported her programming system would not turn on.The handheld was reportedly charged for a few hours and would not turn on at all.No patient therapy was reportedly affected.There was no physical damage noted on the handheld.The handheld was returned to the manufacturer for review.Product analysis has not been completed to date.

Event Description

The handheld and software/flashcard were returned for analysis.The handheld was received with the backup battery status indicating a low battery, which is an expected event.The handheld was charged using the returned ac power cable and verified to fully charge.The handheld was used continuously for over an hour using only the main battery after being charged.No anomalies were identified with the handheld or the returned ac adapter cable and the handheld was verified to perform according to functional specifications.An analysis was performed on the returned flashcard/software and confirmed that the flashcard and software also performed according to functional specifications.No anomalies were identified during analysis of the software.

• 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: 5873653
• MDR Text Key: 52390219
• Report Number: 1644487-2016-01824
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

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: 1073772
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2010
• 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