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

Model Number MODEL 250

Device Problems No Display/Image (1183); Loss of Power (1475); Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/31/2016

Event Type  malfunction  

Event Description

It was reported that a physician's handheld screen would fade to a dark screen and shut off.A hard reset was performed, but the issue continued.It was noted that the battery in the handheld had bubbled up.No further relevant information has been received to date.

Manufacturer Narrative

The initial report inadvertently did not include the patient identifier.The initial report inadvertently listed the age as na instead of ni.The initial report inadvertently listed the sex as na instead of ni.The initial report inadvertently listed the weight as na instead of ni.The initial report inadvertently listed the incorrect aware date.The correct date was (b)(6) 2016 instead of (b)(6) 2016.

Event Description

Further information was received indicating that a patient's device was unable to be communicated with due to the handheld not being functional; however, the patient's device was successfully communicated with at a later date using a different programming system.The handheld has not been received to date.

Event Description

The handheld was suspected to be lost.Therefore, no analysis could be performed.

• 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: 6129241
• MDR Text Key: 61196249
• Report Number: 1644487-2016-02729
• 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
• Report Date: 02/21/2017

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
• Device Lot Number: 885472
• Other Device ID Number: VERSION 8.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/29/2016; 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2008
• 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