MAUDE Adverse Event Report: CYBERONICS, INC. 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 10/05/2010

Event Type  malfunction  

Event Description

During review of the in-house programming/diagnostic history database, it was observed that during interrogation on office visit on (b)(6) 2010 the patient's settings were different than what were programmed at the same office visit.The settings found were indicative of a faulted diagnostic test; however, review of system diagnostic testing from office visit on (b)(6) 2010 was within normal limits.The physician corrected the settings; however, the magnet pulse width was not corrected.The device was interrogated prior to the patient leaving the office on (b)(6) 2010 as recommended by device manufacturer to ensure the device is at the correct settings; however, the physician did not correct the magnet pulse width back to the previous setting.No patient adverse events were reported.

Manufacturer Narrative

Analysis of programming history.

Manufacturer Narrative

Date of birth; corrected data: the initial mfr.Report inadvertently reported the wrong date of birth.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 4205769
• MDR Text Key: 4983190
• Report Number: 1644487-2014-02846
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2013

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 7.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 10/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR