MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number	MODEL 3000
Medical Device Problem Codes	Computer Software Problem (1112); Improper Device Output (2953)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient was visiting the doctor¿s office and their autostim was turned off.The medical assistant had seen an error message but could not remember what it was.The patient was said to have been programmed with the m3000 programming software.No other relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7339779
• Report Number: 1644487-2018-00395
• Device Sequence Number: 1458396
• Product Code: LYJ
• UDI-Device Identifier: 05425025750399
• UDI-Public: 05425025750399
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1