MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

Model Number 201

Device Problems Device Displays Incorrect Message (2591); Application Program Problem (2880); Computer Operating System Problem (2898)

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

Event Date 02/26/2015

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was unable to be interrogated during an office visit on (b)(6) 2015.Several minutes would pass when initiating the interrogation process with the programming system until a failure message would appear.There were no issues found with the wand battery, the connection between the wand and serial adaptor, and the serial cables.The physician re-attempted to interrogate the patient¿s device by rotating the programming wand 45 degrees and ensuring the programming wand was at least 2-3 feet from all other electrical equipment; however, the issues continued.It was noted that data transfer indicator on the programming wand was not blinking when attempting the interrogations.The physician stated that these attempted interrogations were not taking place in the normal office, but no sources of emi were noted in the current surroundings.The patient¿s device was not programmed to high settings and the patient did not have any recent surgeries where electrocautery was used.No further information relevant to the event has been received to date.The issues associated with the programming wand will be reported in the next quarterly alternative summary report.

Manufacturer Narrative

Event Description

A company representative met with the patient and nurse practitioner on (b)(6) 2015 and watched them perform an interrogation.The representative noticed that the patient was holding the programming wand in an incorrect position (too far away from the device) and because of that the handheld device was unable to communicate with the patient¿s generator.The programming wand just needed to be closer to the generator and after that adjustment, everything worked perfectly.

• Brand Name: PROGRAMMING WAND
• Type of Device: PROGRAMMING WAND
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4632884
• MDR Text Key: 5755196
• Report Number: 1644487-2015-04243
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/26/2015

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: 03/31/2016
• Device Model Number: 201
• Device Lot Number: 202947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 03/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR