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

Model Number MODEL 250

Device Problems Intermittent Continuity (1121); Loose or Intermittent Connection (1371)

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

Event Date 05/10/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016 it was reported that the usb cable is "loose" at the connection port and intermittently working.The device has not been returned for product analysis to date.

Manufacturer Narrative

Initial mdr inadvertently omitted information known prior to submission of the mdr.

Event Description

It was reported that the operating room specialist that she attempted to use a second cable on the tablet and the connection worked but was still a little loose.Information received on 07/06/2016 indicated that multiple cables have been used and these are also loose at the connection port.She has to orient the cable in a certain way in order for the tablet and usb connection to work.The tablet is expected to be returned but has not been received to date.

Event Description

The company representative's tablet was received on 09/29/2016 and product analysis was performed on it.Product analysis found no anomalies with the tablet.The loose cable could not be replicated.No anomalies were found with the accessories of the tablet either.The company representative's claim of a loose cable could not be confirmed.

• 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: 5700547
• MDR Text Key: 47893260
• Report Number: 1644487-2016-01258
• 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: 05/10/2016

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: Other
• Device Model Number: MODEL 250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/29/2016; 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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