MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Interrogate (1332); Device Displays Incorrect Message (2591)

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

Event Date 06/15/2016

Event Type  malfunction  

Event Description

It was reported that the patient's generator could not be interrogated.The physician doesn't suspect that the generator battery is depleted.He reported that he was able to interrogate the patient's device in (b)(6).On (b)(6) 2016, the physician reported that the programming system screen froze when he tried to program.He performed a hard reset.He was then able to proceed to attempt to interrogate.At that point he kept getting communication error messages, and was unable to interrogate the patient's device.He saw another patient later and the programming handheld was able to interrogate their device.As the physician was not with a patient when he called, no troubleshooting could be performed on the phone.He reported that the device was not plugged into the wall.He reported that the 9v battery was changed in the wand, but he was still unable to interrogate the initial patient's device.A company representative was able to check the programming system but couldn't replicate the issue with the demo generator.

Event Description

Additional information was received that the physician was able to interrogate patient's generator without any issues on (b)(6) 2016.The programming system was working fine and successfully interrogated the patient's generator.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: 5780680
• MDR Text Key: 49831634
• Report Number: 1644487-2016-01545
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 102
• Device Lot Number: 202425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2013
• 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: 55 YR