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

Model Number MODEL 250

Device Problem Operating System Version or Upgrade Problem (2997)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2015

Event Type  malfunction  

Event Description

A company representative reported that he was unable to complete a software upgrade for a tablet programmer.When he powered the device on, it wouldn't boot up.He received the error message, "no bootable drive." he performed a forced reboot, which was successful in booting up the device.Later on during the upgrade procedure, the tablet did not reboot.The tablet programmer has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

Type of device, corrected date, initial mdr submitted on programming software, corrected to programming computer corrected data, udi for suspect device inadvertently omitted from initial mdr: suspect device udi: (b)(4).

Event Description

Product analysis was completed for the tablet device on 10/02/2015.During the analysis, it was identified that the hard drive was not being recognized by the tablet during startup.The cause for the anomaly is associated with a loose cable connection between the hard drive and main board.Once the cable was reseated onto the main board the tablet was able to recognize the hard drive, however during startup windows failed to start.The cause for the anomaly is associated with a missing/corrupt file associated with the os.The most likely cause for the file anomaly is associated with the loose cable.Once the cable was reseated and the os was reinstalled, no further anomalies were identified.

Event Description

It was determined that the cause of the loose cable connection between the tablet's main battery and the motherboard was due to poor quality connection of cable to motherboard during manufacture.The root cause for this cable connection failures remain to be a likely suboptimal connection at the time of tablet manufacture, which then leads to the connections being susceptible to loosening over time due to shock and vibration from use.These failure modes are likely the result of latent failures present during manufacture due to inadequate supplier quality.

• 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: 5115753
• MDR Text Key: 27591656
• Report Number: 1644487-2015-05928
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Followup,Followup
• Report Date: 09/02/2015

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 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/27/2015; 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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