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

Model Number MODEL 250

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Inadequate Lighting (2957)

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

Event Date 08/22/2014

Event Type  malfunction  

Event Description

It was reported that the physician's wand was not working properly.A known working wand was used with the physician's programming computer and worked.It was reported that the wand data received light would not illuminate.The physician's office was provided a new wand and the wand was returned for analysis.Analysis of the wand was completed on 09/09/2014.Analysis confirmed the integrity of the serial data cable continuity was not compromised by the dislodged strain-relief grommet.Internal visual inspection found the j1/p1 connections were intact.It is not known why the strain relief grommet became dislodged from its intended location.Although there was a visual anomaly with the strain relief grommet, the programming wand performed according to functional specifications.It is unknown if the physician's computer serial cable was used when the troubleshooting was performed and whether or not the system is working with the new wand.No additional relevant information has been received to date.

Event Description

Additional information received revealed that the programming system is functioning properly with the new programming wand.

• 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: 4153134
• MDR Text Key: 4911478
• Report Number: 1644487-2014-02592
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 10/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2015
• 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