MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Failure to Charge (1085); Failure to Power Up (1476); Temperature Problem (3022)

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

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the programming tablet was hot.The following day the tablet would not turn on.A company representative attempted to perform troubleshooting and confirmed that the tablet would not turn on.The company representative attempted to charge the tablet using multiple power outlets and multiple ac power adapter's however the tablet would still not charge.The physician did not require a replacement tablet since she had an additional tablet available.The suspect tablet was sent back to the manufacturer however it has not been received to date.

Event Description

The suspect tablet was received and is currently pending product analysis.

Event Description

Product analysis was completed on the tablet which was received with a depleted main battery.The tablet was powered using a known good ac power supply with no observed anomalies.The tablet booted to the vns welcome screen.The tablet was then successfully used to perform interrogations and diagnostic testing.The tablet was powered-on continuously for one hour and after the hour 73% of the battery remained.During analysis no temperature anomalies associated with the battery temperature were identified.The tablet performed to functional specifications.It was noted that the tablet was received without the ac power supply therefore analysis could not determine if it contributed to the reported events.

• Brand Name: PROGRAMMING COMPUTER
• 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: 6130636
• MDR Text Key: 61294651
• Report Number: 1644487-2016-02742
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1