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

Model Number MODEL 250

Device Problems Premature Discharge of Battery (1057); Break (1069)

Patient Problem No Information (3190)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

It was reported that a clinic's tablet had a broken screen and that the battery will not hold.The tablet is expected to be returned and a replacement tablet was provided.Additional information was received that the tablet was inadvertently dropped.No other relevant information was available.The tablet was received on (b)(6) 2016.Analysis is underway but has not been completed to date.

Event Description

An analysis was performed on the returned tablet and the reported allegation of cracked screen was verified.A visual inspection of the tablet verified that the display was cracked.Although the screen was cracked, the tablet was still able to complete testing with no observed anomalies.No further anomalies associated with the tablet were identified during the analysis.An analysis was performed on the returned tablet and the reported allegation of battery not holding charge was not verified.No anomalies associated with the man battery were identified during the analysis.

• 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: 6178071
• MDR Text Key: 62844514
• Report Number: 1644487-2016-02872
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2014
• 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