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

Model Number MODEL 250

Device Problems Break (1069); Crack (1135); Material Frayed (1262); Device Displays Incorrect Message (2591)

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

Event Date 06/17/2015

Event Type  malfunction  

Event Description

It was reported that the tablet device displayed an "unable to open port" error message.The usb serial cable was replaced and the issue resolved.It was noted that the programming wand was cosmetically damaged; the wand functioned normally but the wand serial cable was cracked and frayed.The usb serial cable and the programming wand were returned to the manufacturer for analysis.The handle strain relief of the programming wand was found to be damaged.Although there was damage to the handle strain relief, this condition had no adverse impact on device performance.The programming wand performed according to functional specifications.Analysis of the returned usb serial cable is currently underway.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

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

Event Description

Analysis of the usb serial cable found that the cause for the reported allegation is associated with a disconnected wire connection in the returned serial cable.Once the wire was soldered onto the serial cable pcb, no further anomalies were identified.

• 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: 4906313
• MDR Text Key: 6835629
• Report Number: 1644487-2015-05150
• 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
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1