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

Model Number MODEL 250

Device Problems Material Frayed (1262); Device Inoperable (1663); Difficult or Delayed Activation (2577)

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

Event Date 08/07/2015

Event Type  malfunction  

Event Description

It was reported that the physician had trouble with dosing during the implant surgery with the hhd.It was mentioned that the hhd touch screen was not functioning and that the hhd performance was very slow.The device was used to check the impedance during a new implant but not all parameters were able to be programmed due to this issue.Additional information was received that the hhd touchscreen function was not working even after a hard reset.The serial cable was also reported to be frayed.The hhd and flashcard were received on (b)(6) 2015 but analysis has not been completed to date.

Event Description

An analysis was performed on the returned handheld.During the analysis it was verified that the touchscreen was unresponsive.The cause for the anomaly is associated with debris that was trapped between the hhd case and display.Once the screen was cleaned and the debris was removed, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.An analysis was performed on the returned flashcard and the reported allegation was verified.No anomalies associated with flashcard software were identified during the flashcard analysis.

• 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: 5050402
• MDR Text Key: 25507288
• Report Number: 1644487-2015-05681
• 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
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• 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: 1075226
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2005
• 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
• Patient Age: 38 YR