MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Programming Issue (3014)

Patient Problem Shock (2072)

Event Type  malfunction  

Event Description

During review of the manufacturer¿s in-house programming database, it was identified that a programming anomaly occurred sometime between (b)(6) 2014 and (b)(6) 2015.On (b)(6) 2014, the device was interrogated at intended settings.There is no diagnostic history available for this date.On the next recorded visit dated (b)(6) 2015, the first interrogation the settings were found to be at unintended parameters that were indicative of faulted system diagnostic tests.Upon follow-up with the treating physician, the physician reported that when he checked the patient¿s device in (b)(6) 2015, he remembers that there appeared to be an ¿electric zap¿ (i.E.Jolting/painful sensation) which scared both the patient and physician.The jolting sensation had stopped on that visit but it did scare her so she¿s reluctant to let him check her device too often.The last couple of times, he has not checked her device but the physician reports that she seems to be doing very well.He reports that he believes he is the only person that would have checked the patient's device around that time.The findings from the programming history were explained to the physician, and the physician expressed understanding.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS; 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: 5447374
• MDR Text Key: 39197547
• Report Number: 1644487-2016-00361
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR