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

Model Number MODEL 250

Device Problems Failure to Power Up (1476); Failure to Reset (1532)

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

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that programming computer could not be turned on, no hard reset was possible to troubleshoot the issue.The programming computer was good charged.A replacement with a tables was requested as the customer will follow up some aspiresr patients.The return of the suspect programming computer is expected but it has not been received to date.

Event Description

It was reported that the suspected programming computer has the serial number (b)(4).

Event Description

The suspected handheld was returned to the manufacturer on 10/10/2016 for the analysis.An analysis was performed on the returned handheld and the reported mechanical problem was not verified.No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.The analysis performed on the flashcard/software showed that no anomalies associated with flashcard software or databases were identified.The handheld and flashcard/software performed according to functional specifications.

• 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: 5924124
• MDR Text Key: 54464310
• Report Number: 1644487-2016-01975
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• 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: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/10/2016
• 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