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

Model Number MODEL 250

Device Problems Break (1069); Loose or Intermittent Connection (1371); Device Stops Intermittently (1599); Battery Problem (2885); Communication or Transmission Problem (2896)

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

Event Date 06/05/2014

Event Type  malfunction  

Event Description

It was reported that the nurse was having intermittent communication issues with her handheld device so a tablet device was used to perform interrogations and diagnostics.The handheld device was fully charged, the wand battery was new, and the power adaptor was unplugged from the electrical socket.Additionally, the nurse performed a hard reset, checked for possible sources of emi, and repositioned the wand when attempting to perform the interrogations.However, the intermittent communication issues continued.The wand was confirmed to be functioning properly.It was noted that the serial cable was damaged and that the connection between the serial cable and handheld was loose.It was previously reported that the handheld device had communication issues, but it was later determined that the issue was due to an uncharged handheld battery.After the handheld was charged, the communication issues resolved.The handheld device and serial cable have been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the returned handheld was completed.The serial cable hood was cracked, and as a result made it difficult to insert into the handheld.No further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

Manufacturer Narrative

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

• 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: 3909590
• MDR Text Key: 4586467
• Report Number: 1644487-2014-01662
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/05/2014

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
• Device Lot Number: 1063524
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/16/2014
• Initial Date FDA Received: 07/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1