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

Model Number 250

Device Problems Battery Problem (2885); Charging Problem (2892)

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

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the company representative, while at the physician's office, that the physician's tablet would not charge.An alternate power cable was used and the tablet was allowed to charge for 20 minutes.She reported that she saw red lights appear when the tablet was charged with an alternate charger and made the assumption that the tablet charger was faulty.It was later reported that the company representative was able to use the tablet while it was plugged into the wall, but it would not turn on at all after being unplugged.The company representative stated she would return the tablet but a replacement was not needed.It was also clarified there were no issues with the power cables and there were no reports of the tablet being dropped or anything of that nature which could have caused an issue.

Event Description

Product analysis (pa) for the returned tablet found the reported allegation of ¿battery failure, will not hold charge¿ was verified.During analysis, it was identified that the main battery was defective and no longer able to hold a charge and power the tablet.Once the battery was replaced with a known good battery, no further 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: 5885207
• MDR Text Key: 52503662
• Report Number: 1644487-2016-01864
• 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
• Report Date: 07/20/2016

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: 250
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• 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