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

Model Number MODEL 250

Device Problems Failure to Power Up (1476); Charging Problem (2892)

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

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that customer had a broken handheld.She reported that the handheld's screen does not turn on after or while the charging of the programming computer.The device is unlocked.The light for recharging the handheld does light.The review of the manufacturing records confirmed all tests passed for the device prior to the distribution.The suspected programming computer was returned to the manufacturer.Analysis is underway but it has not been completed to date.

Event Description

The product analysis was completed on 08/11/2016.The analysis showed that the reported handheld issue was not verified.The testing revealed that the handheld performed according to the functional specifications.No anomalies were identified during the analysis.An analysis was also performed on the returned flashcard and no anomalies associated with flashcard software or databases were identified during the analysis.

• 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: 5864486
• MDR Text Key: 52312710
• Report Number: 1644487-2016-01792
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Assistant
• Type of Report: Initial,Followup
• Report Date: 07/15/2016

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: 1063528
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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