MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Output below Specifications (3004); Programming Issue (3014)

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

Event Date 06/24/2015

Event Type  malfunction  

Event Description

During an internal review of programming and diagnostic history, it was identified that a device which was programmed on (b)(6) 2015 at 1.75ma of output, were found at 0ma output on (b)(6) 2015.When this issue was found, it was corrected on the same date.No patient adverse events were reported.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.No further information was provided to date.

Event Description

Further information was received from the physician indicating that when the patient came to the clinic-visit on (b)(6) 2016 at 09.55 am, the first interrogation revealed the same settings than the previous clinic visit.At 9.59 am, an interrupted system diagnostic test occured, and this was then corrected at the same visit, back to the settings recorded at the first interrogation.Review of manufacturing records confirmed all tests passed for the concerned tablet prior to distribution.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• 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: 5836189
• MDR Text Key: 51944025
• Report Number: 1644487-2016-01719
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

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 11.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2014
• 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: 17 YR