MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Bent (1059); Intermittent Continuity (1121); Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896)

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

Event Date 12/01/2015

Event Type  malfunction  

Event Description

The company clinical support specialist reported that her wand was having intermittent issues.She reported that the wand did not plug into the tablet well, did communicate well, and she recently had to use a physician's programming system to interrogate a generator because her wand was not working.She tried changing the 9v wand battery and holding in the usb connection, but it still reportedly did not work.A replacement wand was provided, but did not resolve the communication issues with her system.The replacement wand was confirmed to be functioning with use on a different programming system.She later reported on (b)(6) 2016 that the tablet port appears to be bent and loose which was suspected to be the cause.There have been intermittent communication issue for around the last three months, but was able to be resolved until the report on (b)(6) 2016.A week prior, the tablet stopped communicating in the o.R.Which required the staff finding another physician's tablet to be used to complete the case.The suspect tablet has not been received to date for analysis.

Event Description

Additional information was received that the communication issues began about two to three months ago and worsened over time until the office was unable to have a successful communication reading.On (b)(6) 2016, the clinical specialist was unable to interrogate a generator.However, the surgery case was successful using a different tablet.Analysis of the programming wand confirmed that it was performing according to functional specifications.The suspect tablet was received by the manufacturer.However, analysis has not been completed to date.

Event Description

An analysis was performed on the returned tablet and the reported allegation was verified.During the analysis, it was identified that the usb port was damaged.As a result, the tablet was unable to establish communication.No further anomalies were identified.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 5555660
• MDR Text Key: 42873720
• Report Number: 1644487-2016-00737
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 11.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/03/2016; 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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