MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

Model Number 201

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Date 03/07/2016

Event Type  malfunction  

Event Description

It was reported by the physician that she was having issues communicating with the patient's vns.The physician noted she was getting an unsuccessful interrogation despite repositioning and checking the wand connections.The patient's vns generator was last communicated with 6 weeks prior.The 9v battery was also checked and confirmed the green power light stayed on for approximately 25 seconds.There was another programming system available, so the physician swapped the serial cable and wand from the known working programming system to the programming system she was currently using and the physician was then able to communicate with the patient's device.It was explained to the physician that either the serial cable or the wand was causing the observed issue.Attempts for additional information have been unsuccessful to date.

Event Description

The programming tablet's serial cable and the programming wand were both returned to the manufacturer for analysis.Analysis which was performed on the serial cabled found there was no mechanical problem.No anomalies associated with the serial cable performance were noted during testing.The serial cable performed according to functional specifications.Analysis which was performed on the programming wand showed that the failure to program was caused due to a depleted battery.The wand passed electrical tests and demonstrated that current consumption rates were within specification, which eliminated any possibility of a condition where a battery might be prematurely depleted by the wand circuitry.Continuity testing of the serial cable and the battery cable passed.No mechanical or visual anomaly was identified.After the battery was substituted, the programming wand performed according to functional specifications.

• 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: 5548424
• MDR Text Key: 42616269
• Report Number: 1644487-2016-00715
• 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: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• 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: 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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: 49 YR