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

Model Number MODEL 250

Device Problem Charging Problem (2892)

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

Event Date 07/30/2014

Event Type  malfunction  

Event Description

It was reported that the physician handheld would no longer hold a charge.It was reported that the physician would leave the handheld plugged into the outlet for many hours and then after unplugging the handheld it would go dead instantly.The physician was provided a new programming tablet.The handheld is expected to be returned for analysis, but has not been received to date.The physician reported that the handheld was stored in a bag locked in his office and no user mishandling contributed to the event.

Manufacturer Narrative

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

Event Description

The handheld device and software flashcard were returned to the manufacturer for analysis.No anomalies associated with the main battery of the handheld were identified during the analysis.It was identified that handheld was unable to charge the main battery.The cause for the anomaly is associated with broken solder connections on the handheld main board.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: 4042262
• MDR Text Key: 4723597
• Report Number: 1644487-2014-02114
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 07/30/2014

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: 584956
• Other Device ID Number: VERSION 7.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 08/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1