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

Model Number MODEL 250

Device Problems Failure to Power Up (1476); Connection Problem (2900)

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

Event Date 01/10/2014

Event Type  malfunction  

Event Description

It was reported that the physician's handheld would not power on after being charged.It was also reported that the handheld wouldn't connect.The physician was provided with a new programming tablet.The handheld is expected to be returned, but has not been received to date.

Event Description

The handheld, flashcard and wand were received for analysis.Analysis of the wand was completed on (b)(4) 2014.¿as received¿ the programming wand did not communicate, which analysis on the pa lab test bench determined was caused by a depleted battery.After the battery was substituted with a known good bench battery, the programming wand passed all communication testing at various orientations.Passing electrical tests demonstrated that current consumption rates were within specification, thereby eliminating any possibility of a condition where a battery might be prematurely depleted by the wand circuitry.Continuity testing of the serial data cable and the battery cable passed.No mechanical or visual anomaly was identified.After the battery was substituted, the programming wand performed according to functional specifications as evaluated through 38-0004-3600.Analysis of the handheld was completed on (b)(4) 2014.No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.Analysis of the handheld was completed on (b)(4) 2014.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.

• 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: 3611359
• MDR Text Key: 4069202
• Report Number: 1644487-2014-00368
• 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: 01/10/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 02/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1