MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

Model Number 201

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

Information was received from the physician that the patient¿s device was able to be interrogated.

Manufacturer Narrative

Model #, serial #, lot#, expiration date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.Operator of device; corrected data: the previously submitted mdr inadvertently provided the wrong device operator for the event.Device manufacture date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.Labeled for single usage; corrected data: the previously submitted mdr inadvertently did not update the suspect device involved in the event.This field should have been updated as the device is not a single use device.Usage of device; corrected data: the previously submitted mdr inadvertently did not update the suspect device involved in the event.This field should have been updated as the device is not a single use device.

Event Description

It was reported that the physician's handheld was unable to communicate with a patient's generator.The physician believed that the wand battery was depleted because the green power light would not illuminate.It was reported that the patient was no longer able to perceive device stimulation.The physician replaced the battery and the wand functioned as intended.The physician plans to bring the patient back in to interrogate the device with the functioning wand, but the patient has not been seen to date.

• 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: 4592633
• MDR Text Key: 5639766
• Report Number: 1644487-2015-04127
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 201
• Device Lot Number: 3836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 61 YR