MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

Model Number 201

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/16/2014

Event Type  malfunction  

Event Description

Additional information was received stating that the programming wand's 9v battery was depleted and caused the reported event.

Event Description

The physician reported that the handheld showed the following error message: "error initiating programming" when he tried to interrogate the patient's vns generator.

Manufacturer Narrative

Brand name, corrected data: supplemental report #1 did not update the product to the programming wand.The product has been updated in this report.Type of device, name, corrected data: supplemental report #1 did not update the product to the programming wand.The product has been updated in this report.Model #, corrected data: supplemental report #1 did not update the product to the programming wand.The product has been updated in this report.Operator of device, corrected data: supplemental report #1 did not update the product to the programming wand and therefore the user would be the physician.The operator of the device has been updated in this report.

• 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: 3630089
• MDR Text Key: 4239490
• Report Number: 1644487-2014-00428
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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