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

Model Number 250

Device Problems Break (1069); Failure to Interrogate (1332)

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

Event Date 02/08/2016

Event Type  malfunction  

Event Description

It was reported the physician was having a difficult time using his programming wand.It was later reported the company representative was having trouble interrogating a patient with the physician's handheld device.Troubleshooting was performed and it was found the battery cover on the wand was broken and originally thought to be the issue; however, this was ruled out as the physician had used the same handheld device with a new wand earlier in the date.Additional troubleshooting was performed and showed handheld device was able to be charged using a known working power cord.The handheld device was working properly after being charged.The faulty power cable was received by the manufacture.Analysis is expected; however, it has not been completed to date.

Event Description

Product analysis for the returned ac power adapter cabled was completed.Analysis was performed on the ac adapter; however, no anomalies associated with the ac adapter performance were noted during testing.The ac adapter performed according to functional specifications.The programming wand was reported to be lost and is not expected to be returned for analysis.

• 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: 5486193
• MDR Text Key: 40139257
• Report Number: 1644487-2016-00496
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 250
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2011
• 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
• Patient Age: 52 YR