MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Energy Output To Patient Tissue Incorrect (1209); Programming Issue (3014)

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

Event Date 05/18/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016 information was received regarding a patient with a m102 generator.Reportedly on the first interrogation during the patient's office visit the patient's generator was not programmed to the settings the physician set.It is currently unclear how the patient's settings were changed at this time.The parameters were reset and the patient was ok.No further addition information has been received to date.

Event Description

It was reported by the physician's nurse that he does have another programming system device that was used to interrogate this patient's generator.The nurse stated that the patient was only seen in (b)(6) , and not in (b)(6), so the data from may was the most recent, but another hand held was used and she believes that device may show that settings changed no additional relevant information has been received to date.

Event Description

Additional programming data was received which showed that a faulty diagnostic test was the cause of the change in settings.This change in settings was corrected by a different programming system during the same visit.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 5912060
• MDR Text Key: 54065488
• Report Number: 1644487-2016-01948
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2017

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 Expiration Date: 06/30/2007
• Device Model Number: MODEL 250
• Device Lot Number: 013620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/12/2016; 01/04/2017; 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR