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

Model Number MODEL 250

Device Problem Reset Problem (3019)

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

Event Date 08/28/2016

Event Type  malfunction  

Event Description

Information was received indicating that the physician was having difficulties with their handheld device.The handheld was continuously rebooting when the wand was plugged in.The handheld was able to hold a charge and no specific screens were seen prior to the hand held rebooting itself.The flashcard was inserted correctly and no patient therapy was affected.The issues first began on (b)(6) 2016.No other relevant information has been received to date.The hand held is expected to be returned but has not been received for analysis to date.

Event Description

The physician's handheld and software were received on (b)(6) 2016 for product analysis which was completed on (b)(6) 2016.No anomalies were identified with the software in the physician's handheld.Product analysis was then performed on the physician's hand held device and an anomaly was identified.The battery of the handheld was swollen causing the battery cover switch to register that the latch was unlocked, thus causing the handheld to power off intermittently.No other anomalies were identified.

• 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: 5969525
• MDR Text Key: 55702785
• Report Number: 1644487-2016-02123
• 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: 08/28/2016

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
• Device Lot Number: 1077281
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/28/2016
• Initial Date FDA Received: 09/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2012
• 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