MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure to Interrogate (1332); Device Displays Incorrect Message (2591); Programming Issue (3014)

Patient Problem Depression (2361)

Event Date 07/21/2016

Event Type  malfunction  

Event Description

It was reported by a medical professional that while attempting to program a patient's device settings a message was received: "procedure failed, diagnostics failed.Unplug the programmer from power, check wand batteries and attempt again." which was indicative of a faulted system diagnostics.The programmer was unplugged from the wall outlet, but was not successful in interrogating afterwards.Upon the patient's follow-up appointment on (b)(6) 2016 she was still unable to establish communication with the generator.She performed a hard reset of the programmer and the generator was successfully interrogated.Upon interrogation the settings were reported to be "zeroed out" indicating the output currents were at zero.She was asked what the intended settings were and she stated 0.25 milliamps.She stated that she had then programmed the patient to intended output of 0.25 milliamps and interrogated the device successfully and confirmed the settings were as intended.The patient stated that since the attempt to perform diagnostics her depression had become worse, which was attributed to the settings being at zero.Additional relevant information has not been received to-date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 5950724
• MDR Text Key: 55122353
• Report Number: 1644487-2016-02079
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Device Lot Number: 1077278
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2005
• 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 Outcome(s): Other
• Patient Age: 64 YR