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

Model Number MODEL 250

Device Problems Battery Problem (2885); Charging Problem (2892)

Patient Problem No Information (3190)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

It was reported that a physician's tablet would not hold a charge.The tablet was reportedly plugged in and left to charge overnight.The tablet powered on while it was plugged in, but when it was unplugged the tablet shut off.The physician had another programming system so no patient therapy was affected.A replacement was provided to the physician.The tablet has not been returned for analysis to date.No further relevant information has been received to date.

Event Description

Product analysis was performed on the tablet and verified that the device functioned per all functional specifications and was verified to operate normally when left on for over an hour.

Manufacturer Narrative

Supplemental mdr #1 inadvertently did not mention that the a/c adapter cable was not provided.Supplemental mdr #1 inadvertently had the incorrect conclusion codes.

Event Description

Product analysis was performed on the tablet and verified that the device functioned per all functional specifications and was verified to operate normally when left on for over an hour.The tablet a/c adapter cable was not returned and an analysis and corresponding conclusions could not be completed for the a/c adapter cable's functionality.

Event Description

The a/c adapter cable was suspected to be discarded.

• 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: 5872583
• MDR Text Key: 52336958
• Report Number: 1644487-2016-01815
• 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,Followup,Followup
• Report Date: 07/20/2016

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: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/09/2016; 10/04/2016; 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2014
• 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