MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problem Use of Device Problem (1670)

Patient Problem Misdiagnosis (2159)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

It was reported that the patient's device was found to be programmed to 0ma.The physician reported that the device was not intended to be at 0ma.It is believed that the device being programmed to 0ma is a result of a faulted diagnostic.The physician reported that the patient was last seen in (b)(6) 2014.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Programming history for the patient was reviewed and it was found that on (b)(6) 2014 a partial programing event occurred and the patient left the consultation with unintended settings.The settings were corrected on (b)(6) 2015.No diagnostics were available for review.

Event Description

It was reported that the patient experienced increased seizures as a result of the device being disabled by the reported programming anomaly.It was reported that the device was switched back on as an intervention.

Event Description

Further information was received stating that the increased seizures debuted on (b)(6) 2015.The events resolved on (b)(6) 2015.The severity was reported as mild.The increase in seizures was reported to be definitely related to stimulation.The adverse event did not cause the subject to be discontinued from the study.The adverse event was not a serious one.

Event Description

Further information was received indicating that the increased seizures debuted on (b)(6) 2015.

Manufacturer Narrative

Review of the available programming and diagnostic history.Age at time of event; corrected data: the previously submitted mdr inadvertently provided an incorrect patient age.Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date.Describe event or problem; corrected data: the previously submitted mdr inadvertently provided incomplete information, as the programming history data was available but it was not described.Relevant tests/laboratory data, including dates ; corrected data: the previously submitted mdr inadvertently provided incomplete information, as the programmed settings data was available but it was not included.Evaluation codes; corrected data: the previously submitted mdr inadvertently provided incomplete evaluation codes.

• 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: 4594449
• MDR Text Key: 5453653
• Report Number: 1644487-2015-04128
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 03/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/17/2015; 04/23/2015; 05/13/2015; 06/16/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 16 YR