MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

Model Number 201

Device Problems Failure to Interrogate (1332); Loose or Intermittent Connection (1371); Programming Issue (3014)

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

Event Date 06/15/2016

Event Type  malfunction  

Event Description

It was reported from the physician's office that the vns programming system wasn't working.It was noted the physician was unable to interrogate the devices of 3 patients; however, they did not believe their were any issues with vns devices.Troubleshooting was performed; however, it was limited as there were no vns generator available to test the programming system with.The programmer was noted to be unplugged from the wall, the wand's battery was checked, the serial cable was unplugged and re-plugged back into the tablet, and the issue still did not resolve.It was later reported by the physician's office that the tablet had a loose usb connector.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported that troubleshooting was performed on the tablet but that the tablet "was a mess".It was later reported by the company representative that, with her troubleshooting, the tablet was found to be working correctly.It was found during the troubleshooting that the wand was actually working incorrectly.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Date of event; corrected data: this information was inadvertently incorrectly reported on the initial mfr.Report.

Event Description

Product analysis (pa) for the returned tablet serial cable was performed and found the reported allegation of a mechanical problem was not verified.No anomalies associated with the tablet serial cable were noted during testing.The tablet serial cable performed according to functional specifications.Pa for the returned programming wand was performed and analysis found that the wand did not communicate.The serial data cable, which produced the communication errors, had intermittent conductors at the handle location.A known good bench serial data cable was substituted and all communication errors cleared.No visual anomalies were identified.Continuity testing of the battery cable passed.After the serial cable was substituted, the device met the specification requirements and the programming wand performed according to functional specifications.

Manufacturer Narrative

Device manufacture date; corrected data: this information was inadvertently left off of the supplemental #02 mfr.Report.

• Brand Name: PROGRAMMING WAND
• Type of Device: PROGRAMMING WAND
• 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: 5787588
• MDR Text Key: 50177015
• Report Number: 1644487-2016-01566
• 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,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2009
• 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