MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure of Device to Self-Test (2937)

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

Event Date 08/04/2006

Event Type  malfunction  

Event Description

A programming anomaly was observed during a review of the manufacturer's in-house programming database.It was observed that a faulted diagnostics test on (b)(6) 2006 resulted in an unintended change in settings which was not corrected until the next visit on (b)(6) 2006.No additional information has been received to-date.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5316791
• MDR Text Key: 34773444
• Report Number: 1644487-2015-06817
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2015

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: 364729
• Other Device ID Number: VERSION 7.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2006
• 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
• Patient Age: 52 YR