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

Model Number MODEL 250

Device Problems Communication or Transmission Problem (2896); Programming Issue (3014)

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

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that a physician's programming system was having communication issues.The physician could not interrogate a patient, but had another system so no patient therapy was affected.Troubleshooting was performed and found that the issue was related to the tablet's serial cable.The manufacturer's sales representative switched programming systems, switched wands, and verified that the issue was with the serial cable.The cable was returned for product analysis.Product analysis identified two disconnected wire connections at the usb to db9 port.Once the wires were soldered back onto the cable pcb, no further anomalies were identified.

Manufacturer Narrative

Other: the initial mdr inadvertently did not include the version number.

• 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: 5976528
• MDR Text Key: 55937301
• Report Number: 1644487-2016-02167
• 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
• Report Date: 09/06/2016

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: Health Professional
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2014
• 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