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

Model Number MODEL 250

Device Problems Intermittent Continuity (1121); Communication or Transmission Problem (2896)

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

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician's office was having intermittent communication issues using the programming system.They had to use another programming system to continue the case.For troubleshooting afterwards, the 9v battery was changed out, the system was not plugged into the wall outlet, and parts were exchanged with known working components with no resolution.No single component could be identified as the source of the issue at the time.The suspect programming system (tablet and wand) was received for product analysis on (b)(6) 2016.Product analysis was completed on the returned wand on 06/22/2016.Other than normal wear related observations, no external visual anomaly was identified with the serial data cable or case.Internal visual inspection of the printed circuit board assembly and associated components revealed no anomaly.Continuity testing of the serial data cable and the battery cable passed.Voltage of the returned battery was 8.81v, above the minimum requirement.The device performed according to functional specifications.Product analysis is underway for the returned tablet.

Event Description

Product analysis for the suspect tablet was completed on 07/08/2016.Included in the analysis are the returned tablet attachments, including the usb to db9 serial adapter cable and an sd card.The tablet was returned without an ac adapter, and the main battery was depleted.Visual inspection identified no anomalies.The tablet was powered using a known good ac adapter with no observed anomalies.The tablet booted to the vns welcome screen with no anomalies.An interrogation was attempted but was unable to be completed.The serial cable's db9 hood was opened and showed that the green data+ wire was no longer soldered on the serial cable pcb.After the wire was soldered onto the pcb, interrogation and diagnostics were performed with no further anomalies observed.The determined cause of the observed wire anomaly was mechanical stress.The tablet's main battery was fully recharged successfully using a known good power supply adapter.Interrogation and diagnostic tests were performed successfully with no observed anomalies.The tablet was powered-on continuously using only the main battery for more than an hour with no anomaly.

• 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: 5766256
• MDR Text Key: 49505702
• Report Number: 1644487-2016-01479
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

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: Health Professional
• Device Model Number: MODEL 250
• Other Device ID Number: VERSION 11.0.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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