MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number 250

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/14/2016

Event Type  malfunction  

Event Description

It was originally reported the handheld programming computer (hhd) had a dead battery and was never used so it was returned to the manufacturer.It was later reported the physician would have to hold the connector cable into the hhd otherwise the hhd's screen would freeze.The programming wand, hhd, and associated software were returned to the manufacturer for analysis.Analysis for the programming wand was approved on (b)(6) 2016 and it was found that the programming wand failed to communicate during functional testing.The serial cable, which produced the communication errors, had intermittent conductors at the handle location.A known good bench serial cable was substituted and all communication errors cleared.No visual anomalies were identified.Continuity testing of the battery cable passed.After the serial cable was substitutes, the device met specification requirements and performed according to functions specifications.Device analysis is expected for the hhd and associated software; however, this has not been completed to date.

Event Description

Product analysis for the returned handheld programming computer was completed and it was found that the reported allegation of a battery failure was not verified.No anomalies associated with the handheld programming computer were noted during testing using the ac adapter, or the main battery with a full charge.The handheld programming computer performed according to functional specifications.Product analysis for the returned software associated with the handheld programming computer was completed.Analysis performed fount no anomalies associated with the flashcard software or databases.The flashcard and software performed according to specifications.

Event Description

Additional clinic notes were received from the physician showing his programming system was not working on (b)(6) 2016.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 5802520
• MDR Text Key: 50622107
• Report Number: 1644487-2016-01618
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2017

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: 250
• Device Lot Number: 1073772
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2016; 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2005
• 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