MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problem Charging Problem (2892)

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

Event Date 01/01/2016

Event Type  malfunction  

Event Description

It was reported that the handheld programmer was not holding a charge and the physician had to keep the handheld programmer connected to the ac power adapter during use.The physician was provided a new tablet programmer.The faulty handheld programmer has not been received to date.

Event Description

The faulty handheld programmer was received and is currently pending product analysis.

Event Description

Product analysis was completed on the suspect handheld programmer and the handheld's software flashcard.Analysis on the handheld programmer found that upon arrival the main battery and back-up battery were depleted.The handheld programmer was then successfully charged using the returned ac power supply.After the main battery was fully recharged the handheld programmer was powered-on continuously for more than an hour performing interrogations and diagnostic tests.After the testing it was noted that the main battery had a remaining charge of 19%.Based on the test results it was determined that the handheld programmer performed according to functional specifications.Analysis on the flashcard found no anomalies associated with flashcard software or databases.

• 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: 5892904
• MDR Text Key: 53620777
• Report Number: 1644487-2016-01891
• 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,Followup
• Report Date: 07/27/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/07/2016; 12/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1