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

Model Number MODEL 250

Device Problems Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896)

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

Event Date 06/16/2014

Event Type  malfunction  

Event Description

It was reported that the serial cable for the handheld device was causing intermittent communication issues due to a loose connection.Troubleshooting was performed and determined the root cause of the issues was the serial cable.The serial cable has not been returned to date.

Event Description

Analysis of the returned handheld serial cable was completed.No anomalies associated with the serial cable communication were identified during the analysis.However, it was identified that the serial cable had 2 open electrical connections in the power plug wire.Because of the open wire connections, the ac adapter was unable to supply power to the handheld.No further anomalies were identified.

Event Description

The handheld serial cable was received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• 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: 3926575
• MDR Text Key: 4580371
• Report Number: 1644487-2014-01751
• 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,Followup
• Report Date: 06/16/2014

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
• Device Lot Number: 1063829
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 07/10/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/14/2014; 09/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1