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 09/01/2016

Event Type  malfunction  

Event Description

It was reported that a physician's programming system had been unable to communicate with their patient's device for some time.No patients were affected as the site had a backup system.A company representative performed trouble-shooting.The handheld was confirmed to not being plugged into the wall at the time of use.A known good wand did not work with the physician's handheld system.Therefore, it was identified either the handheld or serial cable adapter as the source of the problem it was noted that the connection of the adapter to the hhd is loose, but it is unknown if this is the cause.No additional relevant information has been received to date.The suspect product has not been received by the manufacturer to date.

Event Description

It was reported that replacing the serial adapter cable paired with the handheld computer had resolved the communication issues.The suspect cable has not been received by the manufacturer to date.

Event Description

The suspect serial cable was received by the manufacturer for product analysis.Product analysis was completed on the returned serial cable.Visual inspection initially identified no anomalies.It was identified that the serial cable was unable to establish communication using a known good wand and handheld.The cause for the communication difficulties was associated with a broken wire connection on the handheld plug printed circuit board.This cause was most likely due to excessive wear.Once the wire was soldered back onto the plug pcb, the serial cable was able to establish communication between the handheld and wand for all remaining functional tests.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
• 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: 6046846
• MDR Text Key: 58506058
• Report Number: 1644487-2016-02420
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2017

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: 1073773
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/03/2017; 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2007
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1