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

Model Number MODEL 250

Device Problems Failure to Interrogate (1332); Loss of Power (1475); Device Displays Incorrect Message (2591)

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

Event Date 06/24/2016

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2016 that the physician's hand held only works when plugged in and immediately shuts down when unplugged.It was also stated that a patient's device was able to be interrogated but diagnostics were unable to be completed due to emi likely from the hand held needing to be plugged into the wall and causing interference.The physician received a checksum error when trying to perform diagnostics.The wand battery was tested and was fine.The wand was repositioned and confirmed to be over the generator.The physician also tried plugging the hand held into another outlet, and powered it on again.She was unable to interrogate the device due to a checksum error.The hand held has not been received to date.

Event Description

The hand held, dell x50 and 8.1 software was received for analysis on (b)(4) 2016.Product analysis for the hhd, dell x50 was completed and approved on (b)(4) 2016.An analysis was performed on the returned handheld and during the analysis it was identified that the main battery was installed backwards.As a result, the handheld was unable to charge and receive power from the battery.Once the battery was removed and installed correctly, no anomalies associated with the main battery were identified during the analysis.Product analysis for the 8.1 software was completed and approved on (b)(4) 2016.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

• 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: 5813531
• MDR Text Key: 51005231
• Report Number: 1644487-2016-01658
• 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: 06/29/2016

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 8.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2012
• 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
• Patient Age: 12 YR