MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Break (1069); Material Frayed (1262); Failure to Power Up (1476); Device Inoperable (1663)

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

Event Date 07/21/2016

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2016 by a medical professional that their programmer serial cable was frayed and was causing issues establishing communication.The handheld, serial cable, and power cable were received for analysis on 08/01/2016.Analysis was completed on the returned handheld 08/18/2016.A visual analysis of the serial cable was able to identify that the outer insulation was damaged at the cable strain relief.Functional testing of the cable was able to verify that the damage was cosmetic and had no functional impact on the serial cable performance.Also during the analysis it was identified that the handheld would not power on using the ac adapter.The cause for the anomaly was associated with damaged leads associated with the handheld sync connector.Because of the damage, the handheld was unable to receive power from the ac adapter.The leads were soldered to the pcb during analysis.It was also identified that the handheld was received with the lock button in the locked position and the handheld buttons and touchscreen were unresponsive.Once the lock button was moved to the unlocked position no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5890633
• MDR Text Key: 53571519
• Report Number: 1644487-2016-01880
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Device Lot Number: 1073772
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2007
• 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