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

Model Number MODEL 250

Device Problems Break (1069); Charging Problem (2892); Connection Problem (2900)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that the psychiatrist¿s handheld device was unable to be charged for the last several months.The connection between the handheld device and power adaptor would not stay in place and appeared to be damaged.The handheld device has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Analysis of the returned handheld device and software flashcard was completed.No mechanical anomalies were identified during the analysis.It was identified that the main battery was unable to hold a charge and power the handheld.The cause for the identified anomaly is associated with a defective battery.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.

• 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: 4019040
• MDR Text Key: 4848308
• Report Number: 1644487-2014-02045
• 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: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• 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: 523493
• Other Device ID Number: VERSION 7.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1