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

Model Number MODEL 250

Device Problem Failure to Charge (1085)

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

Event Date 09/22/2014

Event Type  malfunction  

Event Description

Analysis of the handheld was completed on 11/07/2014.No anomalies associated with the main battery were identified during the analysis.During the analysis, it was identified that the handheld would not power on.The cause for the anomaly is associated with fluid damage on the main pcb.Once the pcb was replaced, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.Analysis of the flashcard was completed on 11/07/2014.No anomalies associated with flashcard software were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

Event Description

It was reported that the physician's handheld will not charge.The physician left the handheld plugged into the electrical outlet for four straight days and it still would not charge.The battery was removed and reinserted, but this did not resolve the issue.The physician was provided a new programming computer.The handheld and flashcard were received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4210382
• MDR Text Key: 5082726
• Report Number: 1644487-2014-02877
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• 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: 10/09/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1