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

Model Number MODEL 250

Device Problem Failure to Charge (1085)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported by a psychiatrist that her programmer would not hold a charge.The programmer was kept plugged in and charging for two weeks prior to the report.The device was able to power on.The available data could be cleared successfully when prompted.The device would power down after reaching the alignment screen.The battery cover was verified to be closed and locked.The charging indicator was flashing red.The handheld was unplugged and plugged back in again.The device was powered back on again and would turn off after reaching the alignment screen.The suspect device has not been received to-date.No additional relevant information has been received to-date.

Event Description

A company representative visited the site and attempted troubleshooting.A hard reset was unsuccessful.The company representative tried removing and re-inserting the battery and this also did not resolve the issue.The programmer and software were received by the manufacturer where analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed on the returned handheld.No anomalies associated with the main battery were identified during the analysis.During the analysis it was identified that the handheld would not power on using the ac adapter.The cause for the anomaly was associated with damaged solder connections associated with the handheld sync connector.Because of the damage, the handheld was unable to receive power from the ac adapter.The cause for the damage to the solder connections is most likely associated with mishandling of the device as it appears the connector detents were not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the printed circuit board and attached cable receptacle.During the analysis, it was also identified that the handheld was unable to charge the main battery.The cause for the anomaly is associated with broken solder connections on the handheld main board.The battery terminal was soldered onto the handheld main board, and the main battery was fully recharged successfully using the power supply adapter.No other anomalies were identified.Analysis was performed on the flashcard.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
• 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: 5345464
• MDR Text Key: 35538140
• Report Number: 1644487-2016-00019
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• 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: 584949
• Other Device ID Number: VERSION 7.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2008
• 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