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

Model Number MODEL 250

Device Problems Loss of Power (1475); Charging Problem (2892)

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

Event Date 11/27/2016

Event Type  malfunction  

Event Description

It was reported that a tablet won¿t hold a charge.It will work if kept plugged in but once unplugged, it turns off.The malfunctioning tablet has not been received for analysis to date.

Event Description

The tablet was received for analysis on (b)(6) 2016 with the serial adapter and power supply.Product analysis for the tablet was completed and approved on (b)(6) 2016.An analysis was performed on the returned tablet and during the analysis it was verified that the main battery was defective and no longer able to hold a charge.It was attempted to charge the main battery overnight, but was unable.After 24 hours of charging the battery gauge button was still flashing amber.Once the main battery was replaced with a known good battery, no anomalies associated with the tablet 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, 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: 6119088
• MDR Text Key: 60877975
• Report Number: 1644487-2016-02700
• 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,Followup
• Report Date: 10/27/2016

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: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2014
• 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