MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

Model Number 201

Device Problems Failure to Interrogate (1332); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the physician¿s office that their programming system wasn¿t working properly for a few weeks as they kept getting an error during interrogation on (b)(6) 2016.A company representative went to troubleshoot the issue on (b)(6) 2016 and saw that their white serial cable was loose.The company representative replaced the white serial cable with the black serial cable and noted that it was still loose.Despite the change in serial cable, a patient's device could not be interrogated on (b)(6) 2016 after the company representative had left.The physician reported that it started interrogation but never completed the interrogation step.The physician did not have any backup equipment and so the patient was asked to return on (b)(6) 2016.On (b)(6) 2016, the company representative performed additional troubleshooting.She turned the physician's tablet on and received an error that stated ¿unable to configure the serial port.Access is denied¿.She pressed ¿ok¿ and was able to successfully interrogate her demo generator.She performed a hard reset, turned it back on, and reported that there was no error message.She tried interrogating the demo generator again with the physician¿s tablet and was not able to interrogate and received error 315.The tablet was confirmed to be not plugged into the wall.The battery test was performed for the and the green light came on over the power button and stayed on for at least 25 sec.She then tried using the physician's serial cable and the physician's wand with her tablet to interrogate the same demo generator multiple times and that worked fine without any errors.Therefore the issue was isolated to the physician tablet.A replacement tablet was provided to the physician.Company representative later reported that she delivered the new tablet to the physician on (b)(6) 2016 and mentioned that they were still having the same communication issue they were having with the old tablet, where the wand light would blink but it wouldn¿t interrogate.She reported that they tried the new tablet and new serial cable with her wand and it worked fine and was able to interrogate the patient.She re-iterated that they had tried her wand with physician¿s old tablet and it didn¿t work previously but her wand with the physician¿s new tablet did work, so she wasn¿t sure if the physician¿s old tablet and old wand were both broken or what was the issue, but she knew that the new tablet worked with her wand.It was verified that the physician¿s wand was fully connected to the old tablet, that the wand was placed right over the battery, and that the green power light on the physician¿s wand stayed on for awhile when she pressed the two red reset buttons.A new wand was provided as a result.The suspect device has not been received to date.

Manufacturer Narrative

Other, corrected data: version 11.0.Initial mdr inadvertently did not include the software version of the tablet.

Event Description

The suspect tablet was received on 11/22/2016.Analysis is underway but has not been completed to date.

Event Description

Analysis on the wand and tablet were completed.The reported ¿failure to program¿ allegation on the wand was confirmed.The serial data cable, which produced communication errors, had an open conductor.A known good bench serial data cable was substituted and all communications errors cleared.No visual anomaly was identified.Continuity testing of the battery cable passed.After the serial data cable was substituted, the device met the specification requirements.After the serial data cable was substituted, the programming wand performed according to functional specifications.An analysis was performed on the returned tablet and the reported allegation of mechanical problem was not verified.No anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.The tablet 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: 6063227
• MDR Text Key: 58713753
• Report Number: 1644487-2016-02499
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2004
• 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
• Patient Age: 36 YR