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

Model Number HHD, DELL

Device Problems Failure to Charge (1085); Use of Incorrect Control/Treatment Settings (1126); Failure to Power Up (1476)

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

Event Date 08/26/2014

Event Type  malfunction  

Event Description

The handheld and flashcard were received for analysis.Analysis of the handheld was completed on 11/18/2014.The cause for the anomaly is associated with a swollen main battery.The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently).No further anomalies were identified.Analysis of the software was completed on 11/18/2014.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 a death or serious injury.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

Event Description

It was reported that the physician's handheld would not power on after being charged for hours.A hard reset was performed and the screen lock was verified to not be engaged.The battery was removed and reinserted; however, no troubleshooting resolved the issue.A new programming tablet was provided to the physician.The handheld is expected to be returned for analysis, but has not been received to date.

• 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: 4113368
• MDR Text Key: 5105517
• Report Number: 1644487-2014-02444
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HHD, DELL
• Device Lot Number: 1075663
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1